Dr. Alaa Mosbah, MD OBS & GYN: Structural diagram of the H1N1 virus

Radiation exposure during pregnancy

The 5 types of radiation include:
(1) Ionizing rays (x-rays),
(2) Cosmic rays,
(3) Microwaves,
(4) Ultrasound, and
(5) Electromagnetic fields.
1- Ionizing rays
X-rays are the most frequent iatrogenic exposure besides prescription medications. During their careers, all obstetricians and gynecologists are asked about the effects of radiation exposure on a pregnancy, and they are expected to be able to judge the need for diagnostic or therapeutic radiation. The effects of radiation are well studied, but as cohort age and long-term effects become clear, information continues to evolve in this ever-changing field. Knowledge about exposures also changes rapidly.
The primary exposures are diagnostic x-rays, radio-pharmaceuticals, workplace exposures, and environmental exposures such as those that occurred after the Three Mile Island and Chernobyl nuclear reactor accidents, and in Iraq following the Gulf War II. Documented effects include (1) intrauterine lethality, (2)organ malformation, (3)mental impairment, and later-onset (4) leukemia and solid tumors.

X-rays are measured in several types of units, the most important of which are the radiation absorbed dose (rad), which is the measure in the United States, and the gray (Gy), which is an international measure. Both rads and grays typically refer to single-time exposures (eg, diagnostic procedures). The roentgen equivalent man (rem) unit of measure and sievert (Sv) unit are used to quantify radiation exposure over time (eg, environmental releases). Conversion factors for these measurements are 1 Gy equals 100 rad and 1 Sv equals 100 rem.

X-rays have both immediate effects and delayed effects:

A].Immediate effects:

Immediate (deterministic) effects are usually intrauterine, often post-conceptual, effects involving damage to growing and pattern-forming cell populations. If the exposure occurs when cell numbers are few, such as during the blastocyst or pre-implantation stage, very early abortion or implantation failure occurs. These effects demonstrate both a dose-response curve and a threshold below which no effects are observed.
As with other teratogens, the embryonic stage is crucial because windows exist for the appearance of effects. The fetal dose is also critical, and a simple application of a maternal calculated dose should not be substituted.

The damage threshold begins at 0.1-0.15 Gy, which causes abortion at pre-implantation, and extends to 1 Gy, which is associated with fetal death in utero at term. Organogenesis represents a window of sensitivity for the fetus during gestational weeks 3-7. The threshold is thought to be 0.05-0.5 Gy.

Skeletal defects have been noted in humans, most particularly reduced head circumference. Animal data point to more frequent defects of the genitourinary system and eye in addition to skeletal effects. Severe mental retardation is another human effect noted at this threshold (0.05-0.5 Gy). The window for these effects is gestational weeks 8-25. Mental retardation has been noted at maternal doses of 1.5 Gy. Fetuses exposed during weeks 8-25 also demonstrate an onset of effects secondary to radiation. These effects include mental retardation, a downward shift in intelligence quotient (IQ) of 30 IQ units/Gy, lower school performance, and unprovoked seizure. All effects are more severe if the exposure occurs during gestational weeks 8-15. Importantly, note that while infants of normal intelligence remain within 1 standard deviation of normal following exposure, borderline infants are rendered mentally retarded at relatively low exposures.

B].Delayed effects:
These effects do not show a threshold, and they occur in the later years of the exposed individual’s life. Fetal x-ray exposures are associated with later-onset childhood leukemia and solid tumors. The demonstrated relative risk in multiple case-control studies is 1.39 (95% confidence interval: 1.3-1.49). This increased risk was documented by the very large Oxford Survey of Childhood Cancers, and the finding was confirmed by multiple US and European studies. The increased risk is thought to occur following an exposure of 0.05 Gy.

Thyroid cancer in childhood is a special concern. Multiple studies have shown that direct external exposure of children’s thyroids results in an increased frequency of cancer. Such exposures occurred following the Chernobyl accident and during medical procedures. The lag time until detection of cancer is 5 years after exposure. In contrast, in utero exposure during the second and third trimester of pregnancy (eg, Chernobyl, maternal thyroid ablation) is associated with an onset of childhood thyroid cancer before the 5-year lag time; these cancers are associated with increased morbidity and aggressiveness.
Radiation is a dose-dependent teratogen. Below a certain threshold, radiation levels are similar in exposed populations and control populations who have received only background radiation.1 A fetus is most vulnerable to radiation-induced central nervous system damage 8 to 15 weeks after conception . Radiation from x-ray and CT scans is measured in rad, rem, gray, and sievert (1 rad = 1 rem = 0.01 Gy = 0.01 Sv).
The United States Centers for Disease Control and Prevention’s Radiation Safety Committee recommends that fetuses of laboratory workers not receive more than a cumulative dose of 500 mrad during the entire gestation period. This occupational exposure guideline is one-tenth of the safe dose and should not be confused with the teratogenic-threshold dose. Pregnant women exposed to <5000 mrad have similar pregnancy outcomes to controls who have received only background radiation.
Most radiodiagnostic examinations expose fetuses to less than 5000 mrad of radiation .X-ray examination of the abdomen is associated with 250 mrad, and an abdominal CT scan with 3000 mrad. There is no significant increase in major malformations in pregnant women inadvertently exposed to these radiation doses. These women should be reassured and counseled appropriately.

Estimated fetal radiation doses during some common radiodiagnostic procedures
FETAL DOSE (MRAD)
X-RAY

Upper gastrointestinal series
100
Cholecystography
100
Lumbar spine radiography
400
Pelvic radiography
200
Hip and femur radiography
300
Retrograde pyelography
600
Abdominal (kidneys, uterus, bladder) radiography
250
Lumbar spine,

• Anteroposterior
750
• Lateral
91
• Oblique
100
Barium enema
1000
Intravenous pyelogram
480
COMPUTED TOMOGRAPHY

Head
0
Chest
16
Abdomen
3000
Intervention;

Clearly, preventing exposure during the first trimester is advisable. Clear counseling is needed for patients with conditions that require uptake scans or radio-nuclide therapy. Patients should be advised that no known safe dose exists in regard to later-onset childhood cancers. The balancing of risk to both patients (fetus and mother) must take into account the value that any given diagnostic test will have for decision-making. For occupational exposures, the limit is 1 mSv after pregnancy notification.
2- Cosmic rays:
Cosmic radiation is ionizing radiation by heavy particles, such as protons and helium nuclei that originate outside the earth. This form of ionizing radiation is most evident at very high altitudes. Primary exposure requires many in-air hours; therefore, airplane crewmembers and pilots, rather than passengers, are typically at risk.
Relatively few studies have been performed on human exposure to cosmic radiation. Risks are real, but the medical community and the general public have little awareness of them.

Two organizations, the US National Council on Radiation Protection and Measurement (NCRP) and the International Commission on Radiologic Protection (ICRP), provide the following recommendations on permissible doses:
General public - 1 mSv
Aircrews - 20 mSv/y averaged over 5 years (maximum 50 mSv/year)
Fetuses - 2 mSv (not to exceed 0.5 mSv/month)
Notably, aviators generally have a lower overall incidence of cancer compared to the general population. The risks of all other forms of transportation outweigh those of flight, although an association exists between frequent flying and certain specific cancers, most notably brain, colon, and hematopoietic cancers.
Also, ionizing radiation has the previously noted fetal effects of decreased head circumference, mental retardation, and childhood cancer.
Aviation workers can easily exceed the NCRP and ICRP limit recommendations. Charter jet crews and passengers fly at higher altitudes with more consequent exposure. Changes in intensity occur with changes in solar flare activity on the sun, and the intensity may exceed 10 mSv/h at 42,000 ft. The US Federal Aviation Administration and the US Occupational Safety and Health Administration recognize flight crews as individuals exposed to radiation. Computer systems are available to calculate exposures, but these systems are not mandatory.

Intervention;
Health care providers should obtain complete occupational histories and discuss risk of exposure with pregnant patients. Given the variability of exposure and that no easy monitoring is possible, any mandatory cut-off or exclusion of pregnant workers from their jobs would be potentially discriminatory and may lead to risks to the child due to altered socioeconomic status.

3- Microwaves:
Microwaves are a form of electromagnetic radiation with particularly long wavelengths. In contrast to ionizing radiation, which travels in extremely short, high-energy waves, energy in microwave radiation affects objects and cells by thermal action only. Microwaves raise the temperature within cells and are cytotoxic to individual cells only at high exposures. No specific DNA-damaging mechanism exists, and no stochastic effects are observed in exposed populations.

4- Ultrasound:Ultrasound involves the creation of very high-frequency sound, emission of this sound, and analysis of how the sound alters upon encountering objects of different densities when reflected back to the emitter. Physical effects, such as well-contained thermal effects, occur when the vibration at these very high speeds is used (e.g. between the paddles of a harmonic scalpel).The energy of ultrasound is carried by the physical particles of the media and objects affected. The energy does not reach an ionizing level, and no DNA-specific effects are observed.
5- Electromagnetic fields:
Despite multiple studies, including some very large studies, the low-energy electromagnetic fields generated by power lines, video displays, and other electric and electronic devices have no demonstrable effects. Some of these studies have been conducted in response to clusters of events, such as increased spontaneous abortion rates in a specific area.

Infertility evaluation & treatment

This guidance is based on the National Institute for Clinical Excellence (NICE) guideline (February 2004).
Definition :
Infertility is the inability to conceive, but a couple are regarded as infertile if after regular sexual intercourse they have not conceived in 2 years [National Collaborating Centre for Women's and Children's Health, 2004].
Classification :
Infertility is classed as primary in couples who have never conceived and secondary in couples who have previously conceived [National Collaborating Centre for Women's and Children's Health, 2004].
Infertility may be categorized into unexplained (30%), or secondary to ovulatory failure (27%), male factors (19%), tubal factors (14%), or endometriosis (5%) [NHS CRD, 1992; De Kretser, 1997; Templeton, 2000]. The presence of disorders in both the man and the woman has been reported to occur in about 39% of cases [Thonneau et al, 1991; National Collaborating Centre for Women's and Children's Health, 2004].

The prevalence of infertility is around 14% in European countries, affecting one in seven couples [National Collaborating Centre for Women's and Children's Health, 2004].
Of all couples attempting to conceive, 16% are unsuccessful after 1 year. This reduces to 8% after 2 years and 7% after 3 years [National Collaborating Centre for Women's and Children's Health, 2004].
Infertility is more common with increasing age: female fertility declines with age although the effect on male fertility is less clear. With regular sexual intercourse only 6% women aged 35 years and 23% of those aged 38 years will have failed to conceive after 3 years [National Collaborating Centre for Women's and Children's Health, 2004].
The number of couples seeking help has increased although it is not thought that there has been a major increase in the prevalence of infertility. Theories such as a decline in sperm count due to environmental factors are controversial. Behavioural factors such as a tendency to delay childbearing may play a role [Himmel et al, 1997; Templeton, 2000].
Causes of infertility in women
1.Disorders of ovulation
2.Premature ovarian failure
3.Polycystic ovarian syndrome: often associated with 4.hirsutism, obesity, acne, and menstrual irregularity.
5.Hypothalamic-pituitary causes:
6.Anterior pituitary macro or microadenoma may alter 7.prolactin secretion and lead to amenorrhoea and anovulation. Although stress may cause a transient rise in prolactin, levels higher than 1000 ml/litre suggest an adenoma.
8.Hypogonadotrophic hypogonadism: the commonest cause is excessive exercising, being underweight or both. People with anorexia nervosa are normally amenorrhoeic.
9.Sheehan's syndrome (panhypopituitarism most often following massive postpartum haemorrhage or trauma) is now very rare.
10.Kallmann's syndrome (amenorrhoea and anosmia due to congenital lack of hypothalamic production of gonadotrophin-releasing hormone) is rare.
11.Thyroid: hyperthyroidism and hypothyroidism may lead to menstrual disorders and ovulatory dysfunction.
12.Adrenal: Cushing's syndrome and congenital adrenal hyperplasia may cause anovulation.
13.Tubal, uterine and cervical factors
14.Genital tract infection causing tubal damage: chlamydial infection is a major risk factor [Land and Evers, 2002].
15.Previous pelvic surgery causing tubal damage or adhesions, or previous cervical surgery causing scarring or shortening of cervix and, rarely, cervical stenosis.
16.Submucosal fibroids may distort the uterine cavity and impair implantation [Campbell and Monga, 2000].
17.Previous sterilization
18.Cervical mucus defect or dysfunction
19.Endometriosis: tubal distortion and limitation of fimbrial motility due to pelvic adhesions.
20.Drugs :
Nonsteroidal anti-inflammatory drugs, in particular indometacin, can inhibit ovulation.
Chemotherapy with cytotoxic drugs can induce ovarian failure, which may be permanent.
Recreational drugs, such as marijuana and cocaine, have also been associated with impaired ovulatory and tubal function.
[Dukes, 1996; Janssen and Genta, 2000; National Collaborating Centre for Women's and Children's Health, 2004]
21.Other factors
Occupational/environmental factors which may affect fertility include shift work, intense physical workload, pesticides, solvents and formaldehyde [National Collaborating Centre for Women's and Children's Health, 2004].
Psychogenic factors may affect fertility but studies have not consistently shown this [Himmel et al, 1997].
Significant systemic illness e.g. thyroid problems
[Cooke, 1996; Hargreave and Mills, 1998; Chen and Brzyski, 1999; Chambers, 1999; Campbell and Monga, 2000; Hamilton-Fairley and Taylor, 2003; National Collaborating Centre for Women's and Children's Health, 2004; Symonds and Symonds, 2004; HFEA, 2004b]
Causes of infertility in men :
1.Defective spermatogenesis
2.Commonest cause of male subfertility: reduced count of mainly dysfunctional spermatozoa (oligoasthenoteratozoospermia) of unknown cause
3.Congenital, e.g. Klinefelter's syndrome (karyotype 47 XXY, small testes and sterility)
4.Hypogonadotrophic hypogonadism, e.g. Kallmann's syndrome
5.Pituitary causes, e.g. hyperprolactinaemia from a pituitary adenoma
6.Genital tract abnormalities
7.Previous vasectomy
8.Past history of infection, e.g. mumps orchitis; epididymitis and prostatovesiculitis may also lead to infertility
9.Congenital absence of vas deferens: 1-2% of infertile men
10.Testicular tumour: may be palpable on examination
11.Maldescended testes: absence of testes on examination
12.Varicocele: present in up to approximately 25%-40% of subfertile men, although its association with infertility is not clear [Wong et al, 2000]
13. Drugs :
Sulfasalazine, neuroleptics, and nitrofurantoin can affect semen quality and cause oligospermia. The effect is usually reversible on withdrawal of medication [Dukes, 1996; National Collaborating Centre for Women's and Children's Health, 2004].
Chemotherapy with cyotoxic drugs can induce permanent azoospermia [National Collaborating Centre for Women's and Children's Health, 2004].
Beta-blockers, cimetidine, psychotrophic drugs, and spironolactone can cause impotence or ejaculatory dysfunction [National Collaborating Centre for Women's and Children's Health, 2004].
The use of drugs such as anabolic steroids and cocaine can adversely affect the quality of semen.
[Dukes, 1996; National Collaborating Centre for Women's and Children's Health, 2004]
14.Other factors :
Ejaculation disorders, e.g. retrograde ejaculation, impotence
Environmental factors which may affect fertility include agricultural chemicals, X-ray exposure, solvents, and heavy metals [National Collaborating Centre for Women's and Children's Health, 2004].
Antibodies against spermatozoa, e.g. post vasectomy
Exposure of testes to heat
Psychogenic stress and its association with infertility in men is not clear. A higher incidence of male sexual disturbances has been observed in couples undergoing fertility investigation and treatment [Saleh et al, 2003; National Collaborating Centre for Women's and Children's Health, 2004].
Significant systemic illness, e.g. cardiac failure, chronic renal failure, neoplasia, uncontrolled diabetes, liver cirrhosis, thyrotoxicosis.
[Wu, 1996; De Kretser, 1997; Himmel et al, 1997; Hargreave and Mills, 1998; Chambers, 1999; Hirsh, 2003]
Likely outcomes of infertility :
Without treatment
For couples who have been trying for less than a year, the conception rate is between 80% and 90%.
For couples who have been trying to conceive for up to 3 years, the conception rate is about 40% in a 1-year period (equivalent to a monthly fecundity rate of 4-5%) if the woman is aged about 30 years.
For couples who have been trying for more than 3 years, the conception rate is still up to 25% in a 1-year period.
If a male or female subfertility factor has been identified, there is still a likelihood of spontaneous conception, although the success rates may be lower.
[NHS CRD, 1992; Himmel et al, 1997; Hargreave and Mills, 1998; Te Velde and Cohlen, 1999].
With treatment
In vitro fertilization (IVF): the overall live birth rate per treatment cycle is 21.8% (25.1% for women aged less than 38 years). If frozen embryos are used the success rate is about 12% per treatment cycle. After five attempts, just over half of women aged under 34 years will have conceived [HFEA, 2004a; HFEA, 2004b]. One in 20 pregnancies that result in a live birth will be a multiple pregnancy. Twins are much are more common than triplets (ratio of 15:1) [National Collaborating Centre for Women's and Children's Health, 2004].
Intracytoplasmic sperm injection (ICSI): the overall live birth rate per embryo transfer is 28.7% (25.7% for women over 38 years) .
Intrauterine insemination (IUI) has a pregnancy rate of 9% per treatment cycle using ovulation stimulation in couples with unexplained infertility [National Collaborating Centre for Women's and Children's Health, 2004].
Donor insemination (DI) has a live birth rate of about 10-12% with each attempt in women under 30 years, and 9% in women aged 35-39 years [HFEA, 2004b].
Oocyte donation has a live birth rate of 25-40% with each attempt (eggs donated by women under 36 years)[HFEA, 2004b].
Embryo donation has a live birth rate of 16.8% using frozen embryos and 27.3% using fresh embryos [Lee and Yap, 2003].
Gamete intrafallopian transfer (GIFT) has a pregnancy rate of 25-30% in any one treatment cycle [HFEA, 2004b].
Tubal surgery: reported pregnancy rates range between 5% and 50%, with the severity of tubal damage being closely linked to outcome [National Collaborating Centre for Women's and Children's Health, 2004].
Reversal of sterilization: pregnancy rates of up to 85.7% have been reported, although rates depend on the type of previous surgery and age. A successful outcome is more likely in younger women [Cohen et al, 1999; Yoon et al, 1999; Tourgeman et al, 2001; Hanafi, 2003].
Reversal of vasectomy results in subsequent pregnancy rates ranging between 35% and 71% [Himmel et al, 1997].
Medical treatment for male factor infertility is effective only if the cause is hypogonadotrophic hypogonadism, where 80% of men have achieved a positive sperm count [National Collaborating Centre for Women's and Children's Health, 2004].
Medical treatments for ovulatory dysfunction caused by hyperprolactinaemia results in an ovulation rate of 70-80% [Hamilton-Fairley and Taylor, 2003].
Pulsatile gonadotrophin-releasing hormone for hypothalamic amenorrhoea results in conception rates of 80-90% after 12 months' use [Hamilton-Fairley and Taylor, 2003].
Management Issues :
General issues
Assessment and investigations for infertility are not generally advised until the couple have been unable to achieve a pregnancy after a year of unprotected intercourse. Some people who present with concerns about their fertility need only simple reassurance that the chance of conception is 84% in the first year if they do not use contraception and have regular sexual intercourse. About half of couples who do not conceive in the first year will conceive in the second year (a cumulative pregnancy rate of 92%) [National Collaborating Centre for Women's and Children's Health, 2004].
Regular sexual intercourse (two or three times a week) throughout the cycle should ensure that intercourse falls within the fertile period. Timing of intercourse using temperature charts and luteinizing hormone detection methods causes stress and has not been shown to improve conception rates. They are therefore not recommended [Hargreave and Mills, 1998; National Collaborating Centre for Women's and Children's Health, 2004].
Folic acid supplements should be taken whilst trying to conceive and for the first 12 weeks of pregnancy in order to reduce the risk of neural tube defects. Most women should take 400 micrograms daily. A higher dose of 5 mg daily is recommended for women who either have a family history of neural tube defect, who have had a baby with a neural tube defect, who are taking antiepileptic medication, or who have coeliac disease [Wald, 1991; Lumley et al, 2003; National Collaborating Centre for Women's and Children's Health, 2004].
Rubella status should be checked. If seronegative, rubella vaccination is indicated and the woman should be advised not to become pregnant within 1 month of the vaccination. Note: the Department of Health has advised that seronegative women should be vaccinated using MMR (measles, mumps, and rubella) since the Department is no longer able to secure supplies of licensed rubella vaccine [CMO, 2003].
Cervical screening should be offered in accordance with the national cervical screening programme guidance [National Collaborating Centre for Women's and Children's Health, 2004].
For further information see the PRODIGY Preconceptual counselling guidance.
Assessment of the infertile couple in primary care
When should I assess?
Couples who are concerned about their fertility should be offered an initial assessment (history and examination) in primary care. Specifically enquire about lifestyle and sexual history to identify couples who may be less likely to conceive [National Collaborating Centre for Women's and Children's Health, 2004].
Couples who have not conceived after 1 year of regular unprotected sexual intercourse, or have been identified as less likely to conceive, should also be offered initial investigations, e.g. semen analysis, assessment of ovulation, or both [National Collaborating Centre for Women's and Children's Health, 2004].
How should I assess the woman?
History
A full medical, sexual, and social history should include:
Maternal age (fertility decreases with age)
Previous children born to the woman, previous pregnancies and miscarriages (with same or different partner)
Length of time trying to conceive, and frequency and difficulties of sexual intercourse
Length of time since stopping contraception and type of contraception
Menstrual cycle details: including length of cycle and symptoms and signs of ovulation, e.g. ovulatory discomfort, changes in cervical mucus
Cervical smear history and previous pelvic surgery, e.g. appendicitis
Symptoms of pelvic inflammatory disease or endometriosis, e.g. dyspareunia and dysmenorrhoea
Past history of sexually transmitted diseases or pelvic inflammatory disease [World Health Organization Task Force on the Prevention and Management of Infertility, 1995]
Systemic or debilitating diseases including thyroid dysfunction, diabetes, inflammatory bowel disease, and anorexia nervosa
Drug history
Details of occupation for possible exposure to hazards that can reduce fertility, e.g. pesticides, nitrous oxide, formaldehyde and solvents [National Collaborating Centre for Women's and Children's Health, 2004].
Lifestyle factors that may affect fertility, e.g. smoking, alcohol intake, excessive exercise, stress. Excessive travelling that limits optimal coital timing may indirectly affect fertility.
[Chambers, 1999; Symonds and Symonds, 2004]
Examination :
Pelvic examination may identify factors causing infertility, such as vaginal infection or tenderness indicating endometriosis or pelvic inflammatory disease. Bimanual examination may reveal fibroids or an ovarian cyst [Hargreave and Mills, 1998; Chambers, 1999].
Also look for obesity (associated with lower fertility), hirsutism, acne, or both (associated with polycystic ovary syndrome), and galactorrhoea (suggestive of hyperprolactinaemia) [Chambers, 1999].
Initial investigations
Mid-luteal phase progesterone levels should be checked in all women to confirm ovulation. The sample should be taken 7 days before the expected period (day 21 in a 28‑day cycle) [National Collaborating Centre for Women's and Children's Health, 2004].
In women with prolonged irregular menstrual cycles, depending on the timing of menstrual periods, serum progesterone may need to be taken later in the cycle, and repeated weekly thereafter until the next menstrual cycle starts [National Collaborating Centre for Women's and Children's Health, 2004].
Serum gonadotrophins (follicle-stimulating hormone and luteinizing hormone) should be measured in all women with irregular menstrual cycles. Women with high levels of gonadotrophins are likely to have reduced fertility [National Collaborating Centre for Women's and Children's Health, 2004].
Thyroid function tests should only be undertaken in women with symptoms of thyroid disease. Women with possible fertility problems are no more likely than the general population to have thyroid disease [National Collaborating Centre for Women's and Children's Health, 2004].
Prolactin estimation should be reserved for women with an ovulatory disorder, galactorrhoea or a suspected pituitary tumour [National Collaborating Centre for Women's and Children's Health, 2004].
Chlamydia screening. NICE recommends that all women who will be undergoing uterine instrumentation should be tested for chlamydia, as infertility investigations may result in iatrogenic pelvic inflammatory disease. Although the prevalence of Chlamydia trachomatis is only 1.9% in subfertile women, the number of people diagnosed with uncomplicated chlamydia infection has risen steadily since 1993 particularly in the 16-19‑year-old age group. We would therefore recommend that chlamydia screening should be part of the assessment of all women presenting with infertility. If the test is positive, women and their partners should be referred for appropriate management and contact tracing [PHLS et al, 2000; National Collaborating Centre for Women's and Children's Health, 2004].
How should I assess the man?
History
A full medical, sexual, and social history should include:
Previous children born to the man (with same or different partner)
Length of time trying to conceive, and frequency and difficulties of sexual intercourse
Past history of mumps, sexually transmitted diseases, or testicular trauma [World Health Organization Task Force on the Prevention and Management of Infertility, 1995; Kennedy, personal communication, 2004]
Previous surgery e.g. herniorrhaphy
Previous urogenital pathology and treatment, e.g. undescended testis or orchidopexy
Systemic or debilitating diseases, e.g. cardiac failure, chronic renal failure, neoplasia, uncontrolled diabetes liver cirrhosis, thyrotoxicosis [Wu, 1996]
Drug history
Details of occupation for possible exposure to pesticides, X-rays, solvents, paints, chemicals from smelting or welding [National Collaborating Centre for Women's and Children's Health, 2004].
Lifestyle factors that may affect fertility, e.g. smoking, alcohol intake, excessive travelling that limits optimal coital timing, excess exercise, stress, social or occupational situations that may cause testicular hyperthermia.
[Chambers, 1999; Symonds and Symonds, 2004]
Examination
Scrotal examination may reveal lumps (cancer, varicocele, or hernia), small, soft testes, or undescended testes in some cases.
The penis should be examined, including a check of the position of the urethral meatus, for structural abnormalities and signs of infection.
Assess secondary sexual characteristics.
Look for gynaecomastia.
[Cooke, 1996; Hargreave and Mills, 1998; Chambers, 1999]
Initial investigations
One fresh semen specimen should be taken during the initial investigation. The specimen should be produced after 2-3 days abstinence from sex. The specimen should be sent to the laboratory as quickly as possible as analysis should be carried out preferably within 1 hour of production [Chambers, 1999; National Collaborating Centre for Women's and Children's Health, 2004].
Interpret using the World Health Organization (WHO) normal values:
Volume 2 ml or more
Liquefaction time within 60 minutes
pH 7.2 or more
Sperm concentration greater than 20 million/ml
Motility: 50% or more motile (grades a and b) or 25% or more with progressive motility (grade a) within 60 minutes of ejaculation. (Grade a is rapid progressive motility, with sperm moving swiftly, usually in a straight line; grade b is slow or sluggish progressive motility and sperm may be less linear in their progression.)
Vitality: 75% or more live
White blood cells: fewer than 1 million per ml
Morphology >30% normal forms (or >15% based on strict morphological criteria)
If the result of the first semen sample is normal, a repeat confirmatory test should ideally be taken 3 months after the initial test as this allows time for the cycle of spermatozoa to be completed.
If the result of the first semen sample is abnormal then a repeat test should be done. If there is a gross spermatozoa deficiency (azoospermia or severe oligospermia) then the repeat test should be done as soon as possible.
[National Collaborating Centre for Women's and Children's Health, 2004]
Which investigations are not generally recommended?
Basal body temperature charts do not reliably predict ovulation and are not recommended [Guermandi et al, 2001; National Collaborating Centre for Women's and Children's Health, 2004].
Ovulation predictor kits are widely available but there is no evidence that attempts to time intercourse to the menstrual cycle will result in improved conception rates and they are not recommended [Hargreave and Mills, 1998; Chambers, 1999].
The routine use of postcoital testing has no predictive value for pregnancy rates [National Collaborating Centre for Women's and Children's Health, 2004].
Screening for antisperm antibodies should not be offered, as there is no evidence of effective treatment to improve fertility [National Collaborating Centre for Women's and Children's Health, 2004].
Lifestyle advice ;
Smoking
Smoking cessation is advisable for both men and women. Smoking, including passive smoking has been shown to be detrimental to fertility in women [Hughes and Brennan, 1996; Augood et al, 1998; Hull et al, 2000; BMA, 2004]. In men, although there is no clear evidence that smoking delays conception or affects fertility, it may affect sperm quality and general health [BMA, 2004].
Alcohol limitation
Women should be advised to limit alcohol to 1 to 2 units once or twice a week. The evidence for a link between alcohol and female infertility is conflicting, and the limits for safe consumption are not known, but until more is known, low consumption of alcohol when trying to become pregnant and during pregnancy is advisable [DH, 2003; National Collaborating Centre for Women's and Children's Health, 2004].
Men should be informed that alcohol consumption within the Department of Health's recommendations of 3 to 4 units a day is unlikely to affect their fertility. Excessive alcohol consumption can be detrimental to semen quality [National Collaborating Centre for Women's and Children's Health, 2004].
Weight
Weight loss should be encouraged in women with a body mass index (BMI) greater than 29, as this is likely to increase their chance of ovulation and therefore conception. There is no proven association between male obesity and infertility, although obesity is associated with poorer general health, a reduction in sperm motility and increased DNA fragmentation [Rich-Edwards et al, 2002; Kort et al, 2003a; Kort et al, 2003b; National Collaborating Centre for Women's and Children's Health, 2004].
Women who have a body mass index of less than 19 and either amenorrhoea or irregular menstruation should be advised that gaining weight is likely to increase their chance of conception [National Collaborating Centre for Women's and Children's Health, 2004].
Nutrition
A well-balanced diet will contribute to general good health for both partners. Although there is little research on nutritional factors in infertility, there have been studies suggesting that nutritional deficiencies may play a role; e.g. vitamins C, D, E, selenium, zinc, and folate deficiencies may affect sperm quality [Wong et al, 2000].
There is no consistent evidence to link consumption of caffeinated beverages (tea, coffee, and cola) and infertility [National Collaborating Centre for Women's and Children's Health, 2004].
Clothing
Men should be informed that although there is an association between an elevated scrotal temperature and reduced semen quality, it is uncertain whether wearing loose-fitting underwear improves semen quality [Tiemessen et al, 1996; Munkelwitz and Gilbert, 1998; National Collaborating Centre for Women's and Children's Health, 2004].
Secondary and tertiary care management
General issues
Specialist infertility clinics are the referral centres of choice. While many secondary care centres carry out a range of infertility treatments, in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and donor insemination (DI) are usually only offered in tertiary care.
General practitioners may find that because of the strict confidentiality of the Human Fertilisation and Embryology Act, that they may not be sent information about their patient's assisted conception treatment. Sometimes letters will be set from the unit to the patient for them to release to their doctor as they see fit [Braude and Muhammed, 2003].
National recommendations
The Department of Health recommends that each primary care trust offer:
All women aged 23-39 who meet the NICE clinical criteria (see below) a minimum of one full cycle of IVF from April 2005. In the longer term it is expected that primary care trusts will progress towards fully implementing NICE guidance.
Priority to couples who do not already have a child living with them.
NICE recommend that all couples where the woman is aged 23-39 years at the time of treatment and who have an identified cause for their fertility problems (such as azoospermia or bilateral tubal occlusion) or who have infertility for at least 3 years' duration should be offered up to three stimulated cycles of in vitro fertilization treatment [National Collaborating Centre for Women's and Children's Health, 2004].
Assessment in secondary care
Investigations in women normally include tubal patency tests. Women who are not known to have comorbidities (e.g. pelvic inflammatory disease, endometriosis, or previous ectopic pregnancy) should be offered a hysterosalpingogram or hysterosalpingo-contrast-ultrasonography. Women thought to have comorbidities should be offered diagnostic laparoscopy and dye so that tubal and other pelvic pathologies can be assessed at the same time [National Collaborating Centre for Women's and Children's Health, 2004].
Investigations in men include an assessment of the sperm, starting with a review of results obtained from primary care investigations. In men with abnormal sperm, a more detailed examination is carried out which may include microbiological tests, sperm culture, endocrine tests, imaging of the urogenital tract, and testicular biopsy.
Types of fertility treatment
Medical treatment
Ovulation induction with clomifene: clomifene is an effective treatment for anovulation, and may be used in selected women [Hughes et al, 2004]. The following needs to be noted:
The Committee on Safety of Medicines (CSM) recommend that no more than six cycles are given. Long-term cyclical therapy is also not recommended [CSM, 1995; ABPI Medicines Compendium, 2002].
NICE recommends treatment for up to 12 cycles. Use beyond this has been associated with an increased risk of ovarian cancer [Rossing et al, 1994; National Collaborating Centre for Women's and Children's Health, 2004].
Ovarian ultrasound monitoring of at least the first cycle where clomifene is prescribed is important, to titrate the drug to an appropriate dose and reduce the likelihood of multiple pregnancy [National Collaborating Centre for Women's and Children's Health, 2004].
Counselling, with regard to the risks of multiple pregnancy, ovarian hyperstimulation, foetal reduction, and possible risk of ovarian cancer, should be given.
Metformin or laparoscopic ovarian drilling may be offered to women with polycystic ovary syndrome who have not responded to clomifene [National Collaborating Centre for Women's and Children's Health, 2004].
Gonadotrophins may be offered to women with clomiphene-resistant anovulatory infertility, but carry a significant risk of multiple pregnancy. Careful monitoring with ultrasound is needed [Kennedy, personal communication, 2004].
Pulsatile gonadotrophin-releasing hormone and dopamine agonists are other treatments for the induction of ovulation.
Drug-induced ovarian suppression is no longer recommended for women with endometriosis because it does not improve pregnancy rates [Duckitt, 2003; National Collaborating Centre for Women's and Children's Health, 2004].
Dopamine agonists should be offered to women with ovulatory disorders secondary to hyperprolactinaemia. Investigations should be done to exclude a pituitary adenoma or extrapituitary tumour before proceeding with infertility treatment [Hamilton-Fairley and Taylor, 2003; National Collaborating Centre for Women's and Children's Health, 2004].
Gonadotrophin drugs are effective in improving fertility in men with hypogonadotrophic hypogonadism [National Collaborating Centre for Women's and Children's Health, 2004].
Surgical treatment :
Tubal surgery may be effective in women with mild tubal disease. Tubal catheterization or cannulation improves the chance of pregnancy in women with proximal tubal obstruction [National Collaborating Centre for Women's and Children's Health, 2004].
Laparoscopic surgery appears to improve the chance of pregnancy in women with all grades of endometriosis [National Collaborating Centre for Women's and Children's Health, 2004], although the evidence from some of the studies is conflicting [Duckitt, 2003].
Surgery for fibroids should be considered if there is no other explanation for infertility. It is essential for intracavity fibroids [Hart, 2003] and should be considered for intramural fibroids >5 cm in diameter, particularly when they are encroaching on the cavity [Kennedy, personal communication, 2004].
Surgery for varicoceles should not be offered, as it does not improve pregnancy rates [National Collaborating Centre for Women's and Children's Health, 2004].
Surgical correction of epididymal blockage in men with obstructive azoospermia is likely to restore fertility [National Collaborating Centre for Women's and Children's Health, 2004].
Assisted conception
Intrauterine insemination (IUI) is the process, timed to coincide with ovulation, by which sperm is placed in the woman's uterus using a fine plastic tube. Low doses of ovary-stimulating hormones are usually also given, to maximize pregnancy rates. If IUI does not work, people move on to try IVF, or ICSI. Ovarian stimulation combined with IUI increases pregnancy rates in subfertile women with mild endometriosis [National Collaborating Centre for Women's and Children's Health, 2004].
Donor insemination (DI) is the insemination of sperm from a donor into a woman, via her vagina into the cervical canal or into the uterus itself (IUI). Sometimes low doses of ovary-stimulating hormones are used in conjunction with DI, with the aim of increasing pregnancy rates. DI should be considered as an option when the man has no or very few sperm on testicular biopsy or surgical extraction; has had a vasectomy, and reversal has failed or not been tried; or has an infectious disease such as HIV, or where there is a high risk of transmitting a genetic disorder to the offspring [National Collaborating Centre for Women's and Children's Health, 2004].
In vitro fertilization (IVF) involves retrieval of the egg(s), which is mixed with sperm and incubated for 2-3 days; the resultant embryo(s) is then injected into the uterus via the cervix. The Human Fertilisation and Embryology Authority recommends that only two embryos be implanted, to reduce the risk of multiple pregnancy [Braude and Rowell, 2003a; National Collaborating Centre for Women's and Children's Health, 2004].
Intracytoplasmic sperm injection (ICSI) involves an individual sperm being injected directly into the egg, to bypass natural barriers that prevent fertilization. ICSI is used for couples who have failed to achieve successful fertilization through conventional IVF, or where the quality or numbers of sperm is too low for normal IVF to be likely to succeed. ISCI is now the treatment of choice in severe male factor infertility [Kennedy, personal communication, 2004]. It may be worth re-referring to specialist clinics men with very low sperm counts who have been told in the past they cannot be helped [Chambers, 1999; Braude and Rowell, 2003a].
Oocyte donation involves stimulation of the donor's ovaries and collection of eggs, which are then fertilized by the recipient's husband's sperm. After 2-3 days the embryos are transferred to the uterus of the recipient via the cervix, following hormonal preparation of the endometrium. This method is suitable for women who have ovarian failure (either premature, or following radiotherapy or chemotherapy); who have had bilateral oophorectomy; where there is gonadal dysgenesis, including Turner's syndrome, or where there is a high risk of transmitting a genetic disorder. It is also used in certain cases of IVF failure [National Collaborating Centre for Women's and Children's Health, 2004].
Embryo donation. Couples who have had successful IVF or ICSI treatment may decide to donate their spare embryos to help other infertile couples [HFEA, 2004b].
Gamete intrafallopian transfer (GIFT) involves egg retrieval, mixing the eggs with the prepared sperm, and then injecting the eggs (maximum of three) with the sperm into the fallopian tube [Chambers, 1999; HFEA, 2004b]. There is insufficient evidence to recommend its use in preference to IVF in couples with unexplained infertility problems or male factor fertility problems [National Collaborating Centre for Women's and Children's Health, 2004].
[DH, 2004b]
Problems with assisted conception :
Ovulation hyperstimulation syndrome
Ovarian hyperstimulation syndrome (OHSS) generally develops if a woman has had an excessive response to gonadotrophins and has produced a large number of follicles (over 20). It is particularly severe in people with polycystic ovary syndrome who have been treated with human gonadotrophin-releasing hormone analogues. It can follow the use of clomifene in sensitive people, e.g. those with polycystic ovarian syndrome.
OHSS presents:
Early: within 1-5 days of human gonadotrophin injection, soon after egg collection and embryo transfer
Late: 7-14 days after embryo transfer when endogenous human chorionic gonadotrophin (HCG) rises after successful implantation
Symptoms and signs include:
Feeling unwell, nausea, vomiting
Abdominal pain, distension, or both caused by enlarged ovaries and acute ascites
Bowel disturbance--constipation or diarrhoea
Dark concentrated urine due to reduced renal perfusion and low urine output
Dyspnoea due to splinting of the diaphragm secondary to ascites or pleural effusion
Leg and vulval oedema
Seek urgent advice from a specialist unit if OHSS is suspected.
Ectopic pregnancy
Ectopic pregnancy occurs in about 4% of pregnancies that occur after assisted conception. Heterotopic (one embryo in the uterus and one in the tube) pregnancy is extremely rare naturally (one in 30,000 pregnancies) but the rate may be as high as one in 100 pregnancies in women who have had assisted conception [Tal et al, 1996].
[Braude and Rowell, 2003b]
Counselling and information on infertility
It is important to involve both partners in all aspects of management. Discussion of wishes, plans, beliefs, and motives are important [Himmel et al, 1997].
Counselling should be made available to all infertile couples, and may cover these different aspects:
Implications of investigations and treatments
Emotional support for social and psychological issues such as stress
Help with ethical and legal issues, especially for assisted conception
Therapeutic counselling to help people accommodate the feelings they have about their infertility.
Information on infertility is often available locally and should be provided to the couple. National sources of up-to-date information include the Human Fertilisation and Embryology Authority (http://www.hfea.gov.uk/) and the patient organizations CHILD (http://www.child.org.uk/), ISSUE (http://www.issue.co.uk/) and BICA (http://www.bica.net/).
Anonymity of donors
Children born as a result of sperm, eggs, or embryos donated after 1 April 2005 will be able to access the identity of their donor when they reach the age of 18 years. This change in the regulation will not be retrospective. Anybody donating before April 2005 will remain anonymous.
Under existing regulations, when they reach the age of 18 years, people may ask the HFEA to confirm whether they were born as a result of donated sperm, eggs or embryos. Those intending to marry, including those who plan to do so before they reach the age of 18 years, may also ask whether the HFEA register shows that they are related to the person they intend to marry.

High-risk pregnancy

Definition :
High-risk pregnancy is broadly defined as one in which the mother, fetus, or newborn is at or may possibly be at increased risk of morbidity or mortality before, during, or after delivery. Many factors are involved, including maternal health, obstetric history, and fetal disease.

PRECONCEPTIONAL EVALUATION
Preconceptional evaluation and counseling of women of reproductive age has gained increasing acceptance as an important component of women's health.

MATERNAL ASSESSMENT FOR POTENTIAL FETAL OR PERINATAL RISK

INITIAL SCREENING :

History

A. MATERNAL AGE
Extremes of maternal age increase risks of maternal or fetal morbidity and mortality. Adolescents are at increased risk for preeclampsia-eclampsia, intrauterine growth restriction (IUGR), and maternal malnutrition.
Women 35 years of age or older at the time of delivery are at higher risk of pregnancy-induced hypertension, diabetes, and obesity as well as other medical conditions. Chromosomal abnormalities are also more common in infants born to older women, as will be discussed in detail later. An increased risk of cesarean section, preeclampsia, and placenta previa is noted in women with advanced maternal age.
B. MODALITY OF CONCEPTION
It is important to differentiate spontaneous pregnancy from that resulting from assisted reproductive technologies (ART). Use of ART increases the risks of multiple gestation, pregnancy-induced hypertension, and preterm delivery.
C. PAST MEDICAL HISTORY
Specific disease states may adversely affect the outcome of pregnancy for the mother or infant. Pregnancy itself may aggravate certain medical disorders and alleviate others.
D. FAMILY HISTORY
A detailed family history is helpful in determining any increased risk of heritable disease states (eg, Tay-Sachs, cystic fibrosis, sickle cell disease) which may affect the mother or fetus during the pregnancy or the fetus following delivery.
E. ETHNIC BACKGROUND
Population screening for certain inheritable genetic diseases is not cost effective due to the relative rarity of the gene in the general population. However, many genetic diseases affect certain ethnicities in disproportionate amounts, allowing those groups to be screened in a cost-effective way.
F. PAST OBSTETRIC HISTORY
1. Habitual abortion
A diagnosis of habitual abortion can be made after 3 or more consecutive spontaneous losses of a previable fetus. Habitual abortion is best investigated before another pregnancy occurs. If the patient is currently pregnant, as much of the work-up as possible should be performed.
Karyotype of abortus specimen
Parental karyotype
Survey for cervical and uterine anomalies
Connective tissue disease work-up
Screening for hormonal abnormalities (ie, hypothyroidism)
Acquired and inherited thrombophilias
Infectious disease evaluation of the genital tract
2. Previous stillbirth or neonatal death
A history of previous stillbirth or neonatal death should trigger an immediate investigation as to the conditions or circumstances surrounding the event. If the demise was the result of a nonrecurring event such as cord prolapse or traumatic injury, then the present pregnancy has a risk approaching a background risk. However, stillbirth or neonatal death may also suggest a cytogenetic abnormality, structural malformation syndrome, fetomaternal hemorrhage or thrombophilia (fetal or maternal), requiring a similar investigation as above.
3. Previous preterm delivery
The greater the number of preterm deliveries, as well as the degree of prematurity, the higher the risk at present for preterm delivery in the index pregnancy. Despite intense investigation, the incidence of preterm delivery has remained unchanged. Two-thirds of preterm deliveries occur near term (34 to 37 weeks), and these carry minimal fetal or neonatal morbidity. The remaining one-third of preterm deliveries accounts for nearly all of the perinatal morbidity and mortality. Approximately 50% of newborns born under 1000 grams suffer from intracranial hemorrhage, retinopathy of prematurity, or bronchopulmonary dysplasia, all of which carry significant long-term consequences. Approximately 40% of preterm delivery is due to spontaneous preterm delivery, another 40% is due to preterm rupture of membranes, and the remaining 20% is due to iatrogenic preterm delivery (eg, delivery due to preeclampsia or deteriorating fetal status). Spontaneous preterm labor is a complex process, but discrete pathophysiological processes have been identified (but may coexist): maternal and/or fetal stress, ascending genital tract infection, abruption (decidual hemorrhage), and uterine distension. Risk factors for preterm labor include prior history of preterm labor, multifetal pregnancy, vaginal bleeding in more than one trimester, in utero exposure to diethylstilbestrol (DES), uterine anomalies, incompetent cervix, and preterm labor in the index pregnancy. Screening for preterm labor in high-risk patients may include cervical length measurements by transvaginal sonography, fetal fibronectin of cervicovaginal secretions, and salivary estriol.
4. Rh isoimmunization or ABO incompatibility
Blood typing of both parents and maternal antibody screening should be performed at the initial prenatal visit. Women at risk for Rh(D) isoimmunization should be screened for anti-Rh(D) antibody at presentation, at 28 weeks gestation, and at delivery.
5. Previous preeclampsia-eclampsia
Previous preeclampsia-eclampsia increases the risk for hypertension in the current pregnancy, especially if there is underlying chronic hypertension or renal disease.
6. Previous infant with genetic disorder or congenital anomaly
A woman with a previously affected infant should be offered genetic counseling. Screening or testing is available for some defects using maternal blood samples (eg, alpha-fetoprotein; AFP), ultrasonography, amniocentesis, chorionic villus sampling, and DNA analysis.
7. Teratogen exposure
A teratogen is any substance, agent, or environmental factor that has an adverse affect on the developing fetus. Whereas malformations caused by teratogen exposure are relatively rare, knowledge of exposure can aid in the diagnosis and management.
a. Drugs
Alcohol, anti-seizure medications (pheny-toin, valproic acid, etc), lithium, mercury, thalidomide, diethylstilbestrol (DES), coumadin, isotretinoin, etc.
b. Infectious agents
CMV, Listeria, rubella, toxo-plasmosis, varicella, Mycoplasma, etc.
c. Radiation
It is commonly believed that medical diagnostic radiation delivering less than 0.05 Gy to the fetus has no teratogenic risk.

ANTEPARTUM COURSE

Uniform Perinatal Record

A consistent method of recordkeeping which is easily understandable from doctor to doctor and location to location is ideal to manage the high-risk patient. In the event of a transfer of care during a pregnancy, or a review of a previous pregnancy, having a coherent, accessible prenatal record helps avoid duplication of tests and helps to expedite diagnostic confirmation and the onset of treatment. Preprinted records such as American College of Obstetricians and Gynecologists (ACOG) forms provide uniform data for each patient and are helpful in diagnosis as well as in management decision making.
Prenatal Visits

Every prenatal visit is an opportunity to not only screen for problems that may complicate the course of the pregnancy but also to anticipate any problems before they develop. Several factors should be evaluated at each visit.

A. VITAL SIGNS
Fever (> 100.4° F), even without other subjective complaints may be due to a wide source of infectious etiologies. Urinary, pulmonary, and hematological sources of the fever should be considered. Signs or symptoms of chorioamnionitis should be assessed, and if chorioamnionitis is suspected, amniocentesis for microscopy and culture should be considered. Depending on clinical correlation, delivery may be necessary. Very high fevers (> 103° F) may trigger preterm labor and may also have an adverse effect on the early development of the fetal central nervous system. Antipyretics may be necessary to lower the temperature.

B. PULSE
Maternal tachycardia can be a sign of infection, anemia, or both. Isolated mild tachycardia (> 100 beats per minute [bpm]) should be evaluated and followed up. Moderate to severe tachycardia (> 120 bpm) needs immediate evaluation, including but not limited to a hemogram and an ECG.

C. BLOOD PRESSURE

The normal pattern of maternal blood pressure readings is for a decrease from baseline during the first trimester, reaching its nadir in the second trimester, and slightly rising in the third trimester, although not as high as the baseline levels. Repeated blood pressure readings of 140/90 mm Hg 6 hours apart or a rise of 30 mm Hg systolic pressure or 15 mm Hg diastolic pressure should be considered evidence of pregnancy-induced hypertension. Consideration of the patient's medical history, prepregnancy blood pressure, and gestational age should all be considered in forming a diagnosis and management strategy.
D. URINALYSIS

At the first prenatal visit, a clean-catch urine culture and sensitivity should be performed. Any growth should be treated with the appropriate antibiotics. At all subsequent visits, urine dipstick testing to screen for protein, glucose, leukocyte esterase, blood, or any combination of markers is useful in identifying patients with a change in their baseline urinary composition.

Screening Tests :
Screening tests are performed at the appropriate time during the pregnancy.
A. FASTER (FIRST AND SECOND TRIMESTER EVALUATION OF RISK FOR ANEUPLOIDY) TRIAL
Transvaginal sonography between 103/7 weeks and 136/7 weeks to visualize and measure nuchal translucency, along with serum measurements of PAPP-A and free β-hCG is currently being studied in several institutions throughout the United States as a screen for Down syndrome, as well as other aneuploidies and malformations.
B. MATERNAL SERUM ANALYTE TESTING
Frequently known as the “triple screen,” this test includes maternal serum alpha-fetoprotein (msAFP), β-hCG, and estriol. In some institutions, only the msAFP is used, while in other institutions a fourth test, inhibin, is included, making it a “quad test.” The usefulness of this screen is its ability to identify pregnancies at an increased risk for open neural tube defects, as well as for certain chromosomal abnormalities, especially trisomy 21 (75% sensitivity for Down syndrome detection). This test is effective at 15–19 weeks' gestation and can therefore identify an at-risk pregnancy in time to pursue more definitive diagnosis, if desired. It is important to note, however, that the triple screen is not a definitive test and that many positive screens have yielded normal fetuses and many abnormal fetuses have had normal screens.
C. DIABETES SCREEN
Routine screening consists of performing a glucose challenge test between 24 and 28 weeks. The test consists of a 50-g oral glucose load with a plasma glucose level drawn exactly 1 hour after. If the value is over 140 mg/dL, a more specific glucose tolerance test (GTT) should be performed. The GTT involves obtaining a fasting plasma glucose level, giving a 100-g oral glucose load, then drawing plasma levels at 1 hour, 2 hours, and 3 hours after the glucose load. A test is considered positive for gestational diabetes if two out of the four values are elevated.
D. ISOIMMUNIZATION
A patient who is Rh-negative with a pregnancy fathered by an Rh-positive man should be screened for antibodies at the first prenatal visit and again at 24–28 weeks. If there continues to be no antibodies, Rhogam should be administered at 28 weeks to prevent sensitization of the mother during the last trimester and delivery. In the event of a previously isoimmunized patient, the typing and screening performed at the initial visit would detect antibodies, which are reported as a numerical titer. These titers should be followed every 4 weeks to assess for worsening isoimmunization. In the presence of worsening titers, follow-up with amniocentesis may be appropriate. Peak systolic velocity of the fetal middle cerebral artery as determined by sonographic Doppler evaluation has been demonstrated to correlate with degree of fetal anemia, allowing for noninterventional diagnosis and management of fetal isoimmunization; however, the definitive treatment is intrauterine fetal transfusion.
E. BETA HEMOLYTIC STREPTOCOCCUS
This is also known as the group B Streptococcus (GBS) test, and between 10% and 30% of pregnant women are colonized with GBS in the vaginal or rectal areas. Whereas they are usually asymptomatic colonizations, perinatal transmission can result in a severe and potentially fatal neonatal infection. Any documented GBS bacteriuria needs to be treated at the time of diagnosis, as well as intrapartum. Intrapartum antibiotic prophylaxis has been shown to decrease the risk of perinatal GBS transmission. There are two approaches to screening: Screen patients at 35–37 weeks' gestation and treat positive cultures with intrapartum antibiotics, or treat patients based on risk factors with intrapartum antibiotic prophylaxis.

Fetal Assessment

Comprehensive fetal assessment begins in the first trimester with nuchal translucency and continues throughout the pregnancy into labor and delivery. Conceptually, antepartum testing in pregnancies at risk falls into one of two categories: assessment of prenatal diagnosis and assessment of fetal well-being.

A. ASSESSMENT OF PRENATAL DIAGNOSIS
Performed during all trimesters, the techniques used are diverse, and the information obtained varies according to the quality of imaging, depth of investigation, and gestational age of pregnancy.
1. Ultrasound
Ultrasound has had a continuous evolution over the last 20 years, with better equipment being produced each year. Real-time sonography allows a 2-D image to demonstrate fetal anatomy, as well as characteristics such as fetal weight, movement, volume of amniotic fluid, and structural anomalies such as myomas or placenta previa which may affect the pregnancy. 3-D sonography allows volume to be ascertained, creating a three-dimensional appearing image on the 2-D screen, which assists in identifying certain anatomical anomalies. Most recently, 4-D machines have been developed, which produce a 3-D image in real time. As the machines become more technically advanced and the computers that run them become faster, the images obtained will continue to improve and push the boundaries of sonographic prenatal diagnosis.
Diagnostic ultrasonography is widely used in the assessment of the pregnancy and the fetus. It is not, however, the standard of care, nor is it recommended by ACOG for every pregnancy. The indications for ultrasonography are multiple and diverse, and the type and timing of the examination varies depending on the information being sought.
A basic ultrasound examination should provide such information as fetal number, presentation, documentation of fetal viability, placental location, and assessment of gestational age. A limited ultrasound examination is a goal-directed search for a suspected problem or finding. A limited ultrasound may be used for guidance during procedures such as amniocentesis or external cephalic version, assessment of fetal well being, or documentation of presentation or placental location intrapartum. A comprehensive ultrasound examination provides information on fetal anatomy, growth, anomalies, and physiologic complications.
Ultrasound evaluation of fetal anatomy may detect some major structural anomalies. Gross malformations such as anencephaly and hydrocephaly are more commonly diagnosed and rarely missed; however, more subtle anomalies such as facial clefts, diaphragmatic hernias, and neural tube defects are more commonly reported to have been missed by ultrasound. The basic fetal anatomy survey should include visualization of the cerebral ventricles, four-chamber view of the heart, and examination of the spine, stomach, urinary bladder, umbilical cord insertion site, and renal region. Any indication of an anomaly should be followed by a more comprehensive sonogram. Typically, the fetal anatomic survey is performed at 17–20 weeks; however, there is controversy surrounding the potential benefits of an earlier sonogram at 14–16 weeks using the transvaginal probe. The earlier scan allows earlier detection of anomalies that are almost always present by the second trimester, as well as allowing greater detailed viewing of the fetal anatomy by using the higher-resolution vaginal transducers.
2. Aneuploidy screening
Multiple sonographic markers for aneuploidy have been identified. The presence of single or multiple markers adjusts the patient's age-related risk of aneuploidy based on the particular markers present. Such sonographic findings include, but are not limited to:
Echogenic intracardiac focus
Choroid plexus cysts
Pyelectasis
Echogenic bowel
Short femur
Hypomineralization of the fifth digit of the fetal hand
3. Amniocentesis
Amniocentesis is frequently performed under the guidance of ultrasonography. A needle is inserted transcutaneously through the abdominal wall into the amniotic cavity, and fluid is removed. There are many uses for this amniotic fluid, including cytology for detection of infection, alpha-fetoprotein evaluation for neural tube defect assessment, assessment of fetal lung maturity (which will be discussed later in the chapter), and the most common indication of cytogenetic analysis. In this case, amniocentesis is often performed between 15 and 20 weeks' gestation and fetal cells from the amniotic fluid are obtained. Risks associated with the procedure are considered to be very low, with the risk of abortion as a result of amniocentesis considered to be between 1 in 200 to 1 in 450 amniocenteses.
4. Chorionic villus sampling
Chorionic villus sampling (CVS) is an alternative to amniocentesis. It is performed between 10 and 12 weeks' gestation, and can be performed either transcervically or transabdominally. CVS is also performed under sonographic guidance, with the passing of a sterile catheter or needle into the placental site. Chorionic villi are aspirated and undergo cytogenetic analysis. The benefit of CVS over amniocentesis is its availability earlier in pregnancy; however, the rate of abortion is higher—as high as 1%. One disadvantage
of CVS is that unlike amniocentesis, it does not allow diagnosis of neural tube defects.
5. Fetal blood sampling
Also referred to as cordocentesis or percutaneous umbilical blood sampling (PUBS), this is an option for chromosomal or metabolic analysis of the fetus. Benefits of the procedure include a rapid result turnaround rate and the ability to perform the procedure in the second and third trimester. Intravascular access to the fetus is useful for the assessment and treatment of certain fetal conditions such as Rh sensitization and alloimmune thrombocytopenia. There is a higher risk of fetal death, however, when compared to the other methods. Fetal loss rates are approximately 2%, but can vary depending on the fetal condition involved.

B. ASSESSMENT OF FETAL WELL-BEING
1. Fetal monitoring techniques
Assessment of fetal status can be performed using a wide variety of techniques.
a. External fetal monitoring
The external measurement of the fetal heart rate is done by using a continuous beam of ultrasound waves focused on the fetal heart. This ultrasound monitor utilizes Doppler effects to sample the frequency of moving fetal heart valves and the atrial and the ventricular systole. The complex received signal wave is then peak detected and entered into the heart rate monitor. The computer averages several consecutive frequencies, which helps minimize artifact, before the signal is displayed and printed. This process of averaging is called autocorrelation, and produces a fetal heart rate pattern which closely resembles that derived from a fetal ECG, although there is more baseline variability inherent in this method.
b. Internal fetal monitoring
The internal measurement of the fetal heart rate is an invasive procedure, utilizing an electrode attached to the fetal scalp. A bipolar spiral electrode is placed transcervically and penetrates the fetal scalp. A reference electrode is placed on the maternal thigh to eliminate electrical interference. The fetal ECG is detected, and the R wave is the signal used for peak detection and for counting. This signal is very clear, and allows accurate beat-to-beat and baseline variability to be measured. Artifact is kept to a minimum, and there is little need for autocorrelation.
c. Sonographic fetal monitoring
There have been reports of a number of sonographically related surveillance techniques for fetal status published in the literature. Such testing techniques as biophysical profile and Doppler velocimetry have been extensively studied and widely used for antepartum evaluation. Doppler velocimetry is a noninvasive technique based on vascular impedance. Most often, the umbilical artery is utilized for this purpose. Both the peak values as well as the actual waveform can be utilized to identify abnormally growing fetuses, or fetuses at risk of cardiac failure or other adverse outcome. Most of the benefit is seen in growth-restricted pregnancies, and use for generalized surveillance is not recommended. Biophysical profile consists of fetal heart rate evaluation combined with sonographically assessed parameters of fetal well being, including fetal breathing movements, fine motor movement, gross fetal tone, and amniotic fluid volume.
2. Fetal heart rate interpretation
a. Antepartum fetal surveillance
In determining which patients should have antepartum fetal surveillance, a major factor to consider is the lack of evidence that any routine surveillance method results in a decreased risk of fetal death. Therefore, we generally begin monitoring in pregnancies in which the risks of fetal demise are known to be increased. These can include maternal conditions such as antiphospholipid syndrome, lupus, diabetes, or other maternal medical problems. They can also include pregnancy-related conditions such as preeclampsia, IUGR, multiple gestation, poor obstetrical history, or postterm pregnancy.
Antepartum surveillance should include a nonstress test (NST) as a minimum. The addition of sonographic monitoring is common, most often as some variant of the biophysical profile. The criteria for the NST are: baseline between 120 and 160 bpm, the presence of periodic accelerations (ie, two accelerations in 20 minutes) of fetal heart rate of 15 bpm over baseline for 15 seconds, the absence of decelerations of the fetal heart rate, and the subjective assessment of variability of the fetal heart rate. In the case of a nonreassuring NST, further evaluation or delivery depend on the clinical context. In a patient at term, delivery is warranted. Near term, determination of fetal lung maturity can be considered. Remote from term poses a more challenging dilemma to the clinician. If resuscitative efforts are not successful in restoring reactivity to the NST, ancillary tests or testing techniques may prove useful in avoiding a premature iatrogenic delivery for nonreassuring fetal heart rate patterns, since the false-positive rate may be as high as 50–60%.
C. ANCILLARY TESTS
1. Vibroacoustic stimulation
An auditory source, often an artificial larynx, is placed on the maternal abdomen. A short burst of sound is delivered to the fetus. This has proven successful in shortening the duration needed for the test to show reactivity, without compromising the predictive value of the absence of acidosis with a reactive NST.
2. Fetal scalp stimulation
The presence of an acceleration after a vaginal exam where the examiner stimulates
the fetal vertex with the examining finger confirms the absence of acidosis (pH > 7.2).
3. Oxytocin challenge test
This may be used to elicit a confirmatory abnormal fetal heart rate response, with one report showing a better correlation with adverse outcome than the NST alone. Other studies, however, have demonstrated no improvement in predicting morbidity over an NST. This is performed by intravenous infusion of dilute oxytocin until three contractions occur in 10 minutes. A positive test indicates decreased fetal reserve, with a 20–40% incidence of abnormal fetal heart rate (FHR) patterns in labor. A positive test is the presence of a late deceleration after each of the three contractions, a negative test shows no decelerations, and anything else is equivocal. Repetitive variable decelerations are termed “suspicious” and are associated with abnormal FHR patterns in labor, particularly in postterm gestations.
Fetal Maturity Tests
Indications for assessing fetal lung maturity—The American College of Obstetricians and Gynecologists has recommended that fetal pulmonary maturity should be confirmed before elective delivery at less than 39 weeks' gestation unless fetal maturity can be inferred from any of these criteria: Fetal heart tones have been documented for 20 weeks by nonelectronic fetoscope or for 30 weeks by Doppler; and 36 weeks have elapsed since a serum or urine hCG-based pregnancy test was reported to be positive.
A. LECITHIN:SPHINGOMYELIN RATIO
The lecithin:sphingomyelin (L:S) ratio for assessment of fetal pulmonary maturity was first introduced by Gluck and colleagues in 1971. The test depends upon outward flow of pulmonary secretions from the lungs into the amniotic fluid, thereby changing the phospholipid composition of the latter and permitting measurement of the ratio of lecithin to sphingomyelin in a sample of amniotic fluid. The concentrations of these two substances are approximately equal until 32–33 weeks of gestation, at which time the concentration of lecithin begins to increase significantly while the sphingomyelin concentration remains about the same. The measurement of sphingomyelin serves as a constant comparison for control of the relative increases in lecithin because the volume of amniotic fluid cannot be accurately measured clinically. Determination of the L:S ratio involves thin-layer chromatography after organic solvent extraction. It is a difficult test to perform and interpret; care at each step of sample handling is critical for consistent results. The sample should be kept on ice or refrigerated if transport to a laboratory is required. Improper storage conditions can change the L:S ratio since amniotic fluid contains enzymes that can be affected by temperature. The amniotic fluid samples must be mixed well. The presence of blood or meconium can interfere with test interpretation. Bloody samples give false information due to the presence of sphingomyelin in blood and decreased extraction of lecithin by cold acetone techniques in the presence of red blood cells. Therefore, if blood or other particulate matter is present in the amniotic fluid sample, a low-speed, short centrifugation can be used to remove the cellular component.
Interpretation of the results should be carried out with consideration of the individual clinical circumstances. For example, some physicians require a higher L:S ratio for confirmation of fetal pulmonary maturity in pregnancies complicated by isoimmunization or diabetes mellitus.
A threshold value for prediction of lung maturity should be calculated in individual centers by correlation with clinical outcome, because the variation within and between laboratories can be considerable. Empirically, the risk of respiratory distress syndrome (RDS) is exceedingly low when the L:S ratio is greater than 2.0.
B. PHOSPHATIDYLGLYCEROL
Phosphatidylglycerol (PG) is a minor constituent of surfactant. It begins to increase appreciably in amniotic fluid several weeks after the rise in lecithin. Its presence is more indicative of fetal lung maturity as PG enhances the spread of phospholipids on the alveoli; thus, its presence indicates a more advanced state of fetal lung development and function.
PG determination is not generally affected by blood, meconium, or other contaminants; its ability to predict pulmonary maturity is the same whether or not contam-ination is present. This is an advantage for assessing fetal lung maturity status since these substances are commonly found in amniotic fluid.
PG testing is performed by thin-layer chromatography (as for the L:S measurement), so it may be determined alone or in conjunction with L:S testing. It can be reported qualitatively as positive or negative, where positive represents an exceedingly low risk of RDS, or in a quantitative fashion, in which a value ≥ 0.3 is associated with a minimal rate of respiratory distress.
C. FOAM STABILITY INDEX
The foam stability index (FSI) is a rapid predictor of fetal lung maturity and is based upon the ability of surfactant to generate stable foam in the presence of ethanol. Ethanol is added to a sample of amniotic fluid to eliminate the effects of nonsurfactant factors on foam formation. The mixture is shaken and will demonstrate generation of a stable ring of foam if surfactant is present in the amniotic fluid. The FSI is calculated

by utilizing serial dilutions of ethanol to quantitate the amount of surfactant present.
Amniotic fluid samples should not be collected in silicone tubes when this test is planned, as the silicone will produce “false foam.” The discriminating value indicative of lung maturity is usually set at ≥ 47. A positive result virtually excludes the risk of RDS; however, a negative test often occurs in the presence of mature lungs. The presence of blood or meconium interferes with results of the FSI.
D. FLUORESCENCE POLARIZATION
The fluorescence polarization test uses polarized light to quantitate the competitive binding of a probe to both albumin and surfactant in amniotic fluid; thus, it is a true direct measurement of surfactant concentration. It reflects the ratio of surfactant to albumin and is measured by an automatic analyzer, such as the TDx-FLM. An elevated ratio has been correlated with the presence of fetal lung maturity; the threshold for maturity is 55 mg of surfactant per gram of albumin.
Evaluation of the accuracy of TDx measurements has also been studied, specifically in diabetic patients. Despite initial evidence that higher cutoffs were required for diabetics, it is currently believed that the same cutoff for lung maturity can be used for both nondiabetic and diabetic patients.
The accuracy of this test compares favorably with the well-established L:S and PG tests. Blood and meconium contamination interfere with interpretation, although the degree or direction of the interference is unclear. There is insufficient evidence regarding the accuracy of this test for determination of fetal lung maturity in vaginally-collected specimens.
A disadvantage to the TDx-FLM method is the large quantification scale. Values greater than 55 are regarded as mature; however, values of 35–55 are considered borderline. In addition, there is controversy as to whether gestational age should be used in interpreting the TDx for determining the likelihood of RDS. In one report, higher threshold values were needed at earlier gestational ages to determine lung maturity and lower thresholds were required at later gestational ages.
Intrapartum Fetal Surveillance
Assessment of the fetus in labor is a challenging task. Certain techniques that were useful in the antepartum period are no longer accurate, and certain new techniques have become available. With the presence of contractions, fetal heart rate monitoring is no longer a nonstress test. Fetal heart rate assessment is still the initial test of choice. Continuous fetal monitoring and intermittent auscultation have been extensively reviewed, and the evidence does not support one over the other for routine obstetric care. Several reports suggest that continuous monitoring results in higher operative delivery rates without an associated neonatal benefit. For the present, the controversy over routine FHR monitoring remains, but the clinical practice is nearly universal for continuous electronic monitoring of the FHR in hospitals and many birthing centers.
In the intrapartum period, access to the fetus allows for further evaluation in the face of a nonreassuring FHR tracing. Direct measurement of the physiologic status of the fetus is possible after adequate cervical dilation and rupture of the membranes.
A. ANCILLARY TESTS
1. Fetal scalp blood sampling
Capillary blood collected from the fetal scalp typically has a pH lower than arterial blood. A pH of 7.20 was initially believed to be the critical value to identify serious fetal stress and an increase in the incidence of low Apgar scores. However, there is much debate over the accuracy of scalp pH in predicting fetal distress with subsequent neurologic sequelae. Continuous scalp pH during labor was highly successful in defining abnormal FHR patterns associated with acidosis, although the advanced technical skill and expense prohibited widespread use. In fact, despite the correlation with FHR, fetal scalp pH is no longer used in many institutions. The only proven benefits reported for scalp pH testing were demonstration of adverse neurologic outcome with pH < 7.1, and fewer cesarean sections for fetal distress.
2. Fetal lactate levels
Collected in the same fashion as scalp pH, lactate levels demonstrated a higher predictive value than pH as markers of neurologic disability.
3. Fetal pulse oximetry
This has been studied over the past 10 years. Controversy exists over its potential clinical value. There is debate about its accuracy in correlating with acidemia. Studies have demonstrated no benefit in relation to FHR patterns, or in detecting neurologically-compromised fetuses. A recent report demonstrating a reduction in the rate of cesarean section for a diagnosis of distress, without an actual decrease in the incidence of cesareans compared with the control group, raised questions about the usefulness of the test, since it was hoped that it could reduce the cesarean section rate in a manner similar to scalp pH and lactate assays. Clearly, more studies need to be initiated to demonstrate a clear benefit to this test.
B. FETAL HEART RATE PATTERNS
1. Reassuring fetal heart rate patterns
Slight deviations from the normal baseline of 120–160 bpm and some periodic changes are innocuous in the continuum of the fetal heart rate pattern. Early decelerations and bradycardia of 100–119 bpm are believed to be vagally mediated due to fetal head compression, and are not associated with fetal acidosis or poor neonatal outcome. Certain cardiac arrhythmias also pose no threat to the fetus while the fetal heart rate pattern deviates from what is considered “normal.” In fact, the majority of fetal arrhythmias are benign and spontaneously convert to normal sinus rhythm by 24 hours postpartum. Persistent tachyarrythmias are well tolerated, but may proceed to fetal hydrops if present for many hours to days. Persistent bradyarrhythmias are often associated with fetal heart disease, but are seldom associated with hypoxia or acidosis in fetal life or labor. Accelerations and variable decelerations of variable shape and timing are indicative of a normal autonomic nervous system.
2. Nonreassuring fetal heart rate patterns
This category is of more concern to the clinician, and while there is still evidence that the fetus is not acidotic, continuation or worsening of the clinical situation may result in fetal distress. Late deceleration is a smooth fall in the fetal heart rate beginning after the contraction has started, and ending after the contraction has ended. They are associated with a fall in fetal pH and a potential for perinatal morbidity and mortality. Another nonreassuring pattern is the sinusoidal heart rate. It is best defined as a pattern of regular variability resembling a sine wave with a fixed period of 3–5 cycles per minute and an amplitude of 5–40 bpm. The mechanism for the sinusoidal pattern is believed to be a response to moderate fetal hypoxemia, including secondary to fetal anemia. It was previously thought to carry a high perinatal mortality. However, follow-up with serial scalp pH has been successfully performed with no adverse outcome. The significance of sinusoidal heart rate patterns depends on the clinical setting. Variable decelerations may be divided into categories, with the deciding characteristic being the onset and the timing of the return to baseline. If a variable deceleration, no matter how deep, does not have a late component, then the pattern is benign and at most is mild cord compression not associated with acidosis or low Apgar scores. When there is a late recovery, the fetal pH falls progressively during the period of deceleration.
3. Fetal distress patterns
Considerable confusion surrounds the diagnosis of fetal distress. Fetal distress should be defined operationally as a pathological condition of the fetus that is likely to cause fetal or neonatal death or damage to the newborn if left uncorrected for a period of greater than 1 hour. It is often, but not always, associated with fetal acidemia and hypoxemia. These metabolic changes are highly correlated with a decompensated fetal homeostasis, but not necessarily with all nonreassuring .
FHR patterns. There are numerous causes and multiple factors associated with fetal distress; however, only a few fetal heart rate patterns are associated with true fetal distress, including:
a. Undulating baseline
Alternating tachycardia and bradycardia with wide swings, often with reduced variability in between.
b. Severe bradycardia
Fetal heart rate below 100 bpm for a prolonged period of time of at least 10 minutes.
c. Tachycardia with diminished variability unrelated to drugs
d. Tachycardia associated with additional nonreassuring periodic patterns such as late decelerations or variable decelerations with late recovery
With careful interpretation, FHR patterns can be a useful screening test for fetal acidemia and hypoxemia. The monitoring and interpretation of the fetal heart rate is ideally used as a screening tool. The presence of a reassuring FHR pattern is just that, reassuring that there is no fetal acidemia at that time. The absence of a reassuring tracing is not necessarily problematic, and ancillary testing can be performed to eliminate false positives. However, it must be remembered that a given segment of FHR monitoring is a single point in time. Pregnancy and labor are ongoing dynamic states. Maternal and fetal conditions and the processes of gestation, especially labor, are stresses which challenge fetal homeostasis. Fetal stress may be manifested in the FHR pattern, while the fetus remains compensated. The clinician must discriminate between stress and distress, using interpretation and ancillary testing. All monitoring techniques are to be ultimately used as supplements to clinical judgment, to obtain the best outcome of pregnancy.
CONCLUSIONS
Assessing pregnancy to determine risk as well as carefully monitoring pregnancies with a recognized risk begins early in the gestation. Preconceptual counseling of patients with known medical or genetic disorders helps to optimize outcomes. Early and frequent prenatal care allow the care provider to screen his or her patient population to identify pregnancies at risk and act accordingly. Additionally, pregnancies identified as complicated by one or more issues can be followed by assortments of maternal and fetal surveillance techniques to maximize therapeutic treatment.
As technology advances and our ability to both diagnose and treat improve, the methods for assessment and care of the pregnancy at risk will be a constantly changing field.

Conditions Associated With CPP With Available Level of Evidence

1. Gynecological causes of chronic pelvic pain

Ovaries

-Ovarian retention syndrome (residual ovary
syndrome) (A)
-Ovarian remnant syndrome (A)
-Adnexal tumors and cysts (C)
-Accessory and supernumerary ovaries (C)
-Tubo-ovarian abscess
-Ovarian ovulation pain (C)

Fallopian tubes

PID (A)
Chlamydial endometritis or salpingitis
Endosalpingiosis (C)
Endometriosis (A)
Subacute salpingo-oophoritis
Tuberculous salpingitis (A)
Hydrosalpinx
Peritubal adhesions (B)

Uterus

Leiomyoma (B)
Adenomyosis (C)
Intrauterine contraceptive device (C)
Endocervical and endometrial polyps (C)
Atypical dysmenorrhea (C)
Chronic endometritis (C)
Congenital anomalies (Cervical stenosis) (C)

Other gynecological

Extrauterine adhesions (A)
Endometriosis (A)
Pelvic varicosities and pelvic congestion
syndrome (A)
Gynecological malignancies (A)
Post-operative peritoneal cysts (B)
Benign cystic mesothelioma (B)
Pelvic support defects (pelvic ﬂoor relaxation genital
prolapse) (C)
Vulvodynia
Pelvic ﬂoor dysfunction (C)
Chronic pelvic infection (A)

2. Gastrointestinal

Chronic constipation (A)
Irritable bowel syndrome (A)
Inﬂammatory bowel disease (A)
Diverticular disease(C)
Diverticulitis (C)
Carcinoma of the colon (A)
Colitis (C)
Chronic intermittent bowel obstruction (C)
Lactose intolerance (C)
Gastric/duodenal ulcer
Proctalgia fugax (C)

3. GU-Urology

Bladder neoplasm (A)
Urolithiasis (A)
Urethral diverticula (C)
Chronic urethral syndrome (A)
Uninhibited bladder contractions (C)
(detrusor-sphincter dyssynergia) (B)
Urethral carbuncle (C)
Detrusor overactivity(B)
Interstitial cystitis (A)
Chronic urethral syndrome (A)
Chronic and recurrent urinary tract
infections (C)
Recurrent cystitis (C)
Recurrent urethritis (C)
Urethral diverticulum (B)
Radiation cystitis (A)

4. Neurological
Neuralgia/cutaneous nerve entrapment (C)
(surgical scar in the lower part of the
abdomen; usually iliohypogastric
ilioinguinal, genitofemoral, and lateral
femoral cutaneous nerves) (A)
Mononeuropathy and nerve entrapment (A)
Neurologic dysfunction (B)
Sympathetic dystrophy (C)

5. Medical

Heavy metal poisoning (lead, mercury)
Uremia
Porphyria (B)
Shingles (herpes zoster infection) (B)
Abdominal epilepsy (C)
Abdominal migraine (C)
Familial Mediterranean fever (C)

6. Musculoskeletal
Fibromyalgia (A)
Abdominal wall myofascial pain (trigger
points, fasciitis) (A)
Cutaneous nerve entrapment in abdominal
surgical scar (A)
Compression fracture of lumbar vertebrae
Muscular strains and sprains (C)
Chronic fatigue syndrome (A)
Pelvic ﬂoor myalgia (levator ani spasm,
Piriformis syndrome) (A)
Pelvic ﬂoor pain syndrome (A)
Coccydynia (A)
Chronic coccygeal pain (A)
Myofascial pain (trigger points, spasms)
Rectus tendon strain (A)
Low back pain (B)
Poor or faulty posture (A)
Hernias (e.g., obturator, sciatic, inguinal,
femoral, perineal, spigelian, umbilical, and
incisional) (C)
Mechanical low back pain (A)
Scoliosis/lordosis/kyphosis
Disk problems (A)
Degenerative joint disease (C)
Spondylosis (C)
Osteitis pubis (C)
Rectus abdominis tendon pain (C)
Neoplasia of sacral nerve or spinal cord (B)
Spinal injury (C)

7. Psychiatric
Depression (A)
Personality disorders (C)
Bipolar personality disorder (C)
Psychological disorders including
somatization (A)
Eating disorder
School avoidance (C)
Sleep disorders (B)

8. Others
Sexual and/or physical abuse, abuse (A)
(physical or sexual, prior or current)
psychosexual dysfunction
Substance abuse (A)
Psychosocial stress (marital discord, work stress) (A)

Level A: consistent good scientiﬁc evidence of causal relationship to CPP.
Level B: limited or inconsistent scientiﬁc evidence of causal relationship to CPP.
Level C: causal relationship to CPP based on expert opinions. (Adapted from ACOG)

Medications in the Breast-Feeding Mother

Prescribing medications for a breast-feeding mother requires weighing the benefits of medication use for the mother against the risk of not breast-feeding the infant or the potential risk of exposing the infant to medications. A drug that is safe for use during pregnancy may not be safe for the nursing infant.

The mammary tissue in the breast is composed of clusters of milk-producing alveolar cells surrounding a central lumen. The transfer of medication into breast milk is driven primarily by a concentration gradient that allows passive diffusion of nonionized and free (non-protein-bound) medication.
The drug concentration in breast milk is largely determined by the maternal serum drug concentration. This serum concentration tends to be lower with medications that have large volumes of distribution and fluctuates more with medications that have short half-lives.
Retrograde diffusion of the drug from breast milk to plasma may remove a medication from the milk even if the mother has not emptied her breasts. Medications that are highly protein bound, that have large molecular weights or that are poorly lipid-soluble tend not to enter the breast milk in clinically important quantities.
Specific Conditions

ALLERGIC RHINITIS
Pseudoephedrine (Sudafed) is excreted in breast milk in small amounts. According to the AAP, its use is compatible with breastfeeding although it may cause decreased milk production. Diphenhydramine (Benadryl), which is frequently prescribed for children, is also excreted in breast milk in small quantities. Either of these medications can cause lethargy or irritability in infants. To reduce the risk to the infant, the mother can take these medications immediately after breastfeeding. The new, nonsedating antihistamines are not well-studied in breast-feeding and are not rated by the AAP. Because they have fewer effects on the central nervous system and are safe for use in children, these antihistamines are preferred for short-term use in breastfeeding women. For long-term treatment, nasal steroids or cromolyn (Intal) are safer alternatives.

ASTHMA
Inhaled steroids for the treatment of asthma achieve very low levels in maternal plasma and are of no concern for the breastfeeding mother. Fluticasone (Flovent) has the lowest serum levels of the inhaled steroids. Oral steroids such as prednisone (Deltasone) and prednisolone (Delta-Cortef) penetrate into the breast milk poorly and are safe for short-term use. When daily dosages exceed 20 mg, prednisolone may be preferred over prednisone because it has only one peak in activity while prednisone has two peaks in activity—one for the pro-drug (prednisone) and the other for the drug (prednisolone). Infant exposure can be minimized by with holding nursing for four hours after taking the medication.
CARDIOVASCULAR
Diuretics and beta blockers, commonly preferred antihypertensives, are safe for use in lactating women, with some precautions. In general, it is preferable to avoid high dosages of any one medication by either changing medications or adding an additional agent.
Low dosages of thiazide diuretics (e.g., 25 mg per day or less of hydrochlorothiazide [Esidrix]) are excreted in small amounts into the breast milk but do not suppress lactation and, consequently, are compatible with nursing. Beta blockers vary widely in the amount excreted into breast milk. Propranolol (Inderal), metoprolol (Lopressor) and labetalol (Normodyne) are excreted in small quantities and are compatible with breastfeeding even in compromised infants. Atenolol (Tenormin), nadolol (Corgard) and sotalol (Betapace) are excreted in higher amounts, which can lead to hypotension, bradycardia and tachypnea in the infant.
Sustained-release nifedipine (Procardia XL) and verapamil (Calan SR) are excreted into breast milk in amounts that are less than the therapeutic dosage for children. Although diltiazem (Cardizem CD) is rated compatible with breast-feeding by the AAP, the levels found in breast milk are higher than the levels for other calcium channel blockers, so safer alternatives are preferred. Captopril (Capoten) and enalapril (Vasotec) are excreted into breast milk in small amounts. These medications are rated compatible with nursing by the AAP, although they have been studied less than other alternatives.Because neonates are highly sensitive to the effects of angiotensin-converting enzyme (ACE) inhibitors, their use by breast-feeding mothers in the first month of their infants' lives may be of concern.Hydralazine (Apresoline) is excreted in amounts far less than the pediatric dosage and is safe, especially for short-term use following delivery.
DIABETES
Insulin is not excreted into breast milk and is considered safe for use during breast-feeding. Based on studies of the distribution of first-generation sulfonylureas into breast milk, the AAP considers tolbutamide (Orinase) to be compatible with breast-feeding.Information on other diabetic agents is less complete. Glyburide (Micronase) and glipizide (Glucotrol) are highly protein-bound (92 to 99 percent), second-generation sulfonylureas. The nature of their protein binding is nonionic and, therefore, they are less likely to be displaced by other drugs and unlikely to pass into breast milk. If any of the sulfonylureas are used, it is important to monitor the nursing infant for signs of hypoglycemia, such as increased fussiness or somnolence.
The alpha-glucosidase inhibitors, such as acarbose (Precose), have low bioavailability, large molecular size and water solubility, so they are unlikely to be excreted into breast milk in clinically significant amounts.
Because of the potential for serious side effects (e.g., lactic acidosis, hepatotoxicity) in adults, it may be advisable to avoid the use of metformin (Glucophage) and thiazolidinediones (e.g., rosiglitazone [Avandia], pioglitazone [Actos]) until more information is available on their use in breast-feeding.
EPILEPSY
Although anticonvulsants are excreted into breast milk, most mothers who require the use of these drugs can safely breast-feed their infants. Determination of maternal serum drug levels may be a useful adjunct to clinical monitoring of the infant when evaluating the drug exposure of the infant.
Phenytoin (Dilantin) and carbamazepine (Tegretol) are compatible with breast-feeding. Although the AAP considers valproic acid and its derivatives (valproic sodium and divalproex sodium) to be compatible with breast-feeding, some experts recommend against their use during breast-feeding because of the potential for fatal hepatotoxicity in children younger than two years.
During breast-feeding, anticonvulsants other than phenobarbital and primidone (Mysoline) are preferred because the slow rate of barbiturate metabolism by the infant may cause sedation. Infant serum levels may be helpful in monitoring toxicity.
Specific Categories of Medications
ANTIBIOTICS
Penicillins and cephalosporins, which are excreted in milk in trace amounts, are compatible with breast-feeding. A remote possibility exists that the child will experience an allergic reaction to the antibiotic or develop diarrhea caused by changes in gut flora. Trimethoprim-sulfamethoxazole (Bactrim, Septra) is compatible with breast-feeding, but its use should be avoided when nursing infants are younger than two months because of its potential for causing increased bilirubin levels.
Tetracycline is excreted in small amounts in breast milk, but the calcium in breast milk limits its absorption. Although tetracycline is compatible with breast-feeding, other antibiotics are preferred, especially for long-term use.Newer derivatives such as doxycycline (Vibramycin) or minocycline (Minocin) should be avoided because of higher absorption by infants and toxicity in children (e.g., dental staining, decreased bone growth).Quinolones have not been well studied in breast milk and are not rated by the AAP. They should be used in the breast-feeding mother only when other, better-studied options cannot be used and after the risks and benefits have been assessed.
Metronidazole (Flagyl) is rated by the AAP as a drug whose effect on infants is unknown, but it may be of concern because older studies found its use in pregnancy to be associated with mutagenicity.Nevertheless, the amount transferred to the infant through breast milk is much lower than the therapeutic dosage for infants, and no adverse effects have been reported from exposure through breast milk. Following a 2-g dose, cessation of breastfeeding for 12 to 24 hours is recommended by the AAP. Topical preparations of metronidazole (MetroGel-Vaginal) produce very low serum concentrations in the mother and are not a concern.
Fluconazole (Diflucan) is commonly prescribed for yeast infections of the nipple in breast-feeding mothers. It is present in breast milk, but the nursing infant can only ingest 5 percent of the usual pediatric dosage. Although limited information is available, topical antifungal agents, such as clotrimazole (Gyne-Lotrimin) or miconazole (Monistat) produce very low maternal serum concentrations, and their use should pose little risk to the nursing infant.
ANTIDEPRESSANTS
Maternal depression is known to have an adverse effect on parenting and infant development. Tricyclic antidepressants have been shown to have little to no effect on the breastfeeding infant, although the AAP finds most tricyclic agents to be of possible concern.Taking a single daily dose at bedtime will limit the infant's exposure to the medication. The selective serotonin reuptake inhibitors (SSRIs) are generally the first choice of treatment for depression. Sertraline (Zoloft) is likely to be the safest choice among them because it has been studied extensively and because drug levels found in nursing infants are usually minimal.
Fluoxetine (Prozac) use during pregnancy has been well-studied, and many new mothers are already taking it at delivery. Its use during breast-feeding is controversial, however. Fluoxetine's long half-life and potential for accumulation in breast milk has prompted some recommendations to avoid its use in women who are breast-feeding young infants. Colic and fussiness have been attributed to elevated serum concentrations of fluoxetine and its metabolite in nursing infants. Results from a recent study showed a decrease in the level of fluoxetine and its metabolite in the early weeks of life in nursing infants whose mothers were maintained on fluoxetine throughout pregnancy and breast-feeding. This decrease implies an absence of accumulation of fluoxetine during exposure from breast milk. No long-term studies of neurologic outcomes of children with breast milk exposure to SSRIs are available. These children should be observed closely.
At this time, it seems prudent to choose an SSRI with the lowest plasma levels in infants, such as sertraline (Zoloft) or paroxetine (Paxil). Another option is to measure serum concentrations of the SSRI and major metabolites in the infant at two to six weeks postpartum to verify that the medication is not accumulating. If the mother has taken fluoxetine during pregnancy, an infant serum level of fluoxetine and norfluoxetine at about six weeks should reflect drug accumulation from the breast milk instead of continued presence of the prenatal medication
ANALGESICS
Of the nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen (Motrin) is the preferred choice because it has poor transfer into milk and has been well-studied in children. Long half-life NSAIDs such as naproxen (Naprosyn), sulindac (Clinoril) and piroxicam (Feldene) can accumulate in the infant with prolonged use.
Epidural use of bupivacaine (Marcaine), lidocaine (Xylocaine), morphine, fentanyl (Sublimaze) and sufentanil (Sufenta) is generally safe in breast-feeding mothers. Morphine, codeine and hydrocodone are considered compatible with breast-feeding by the AAP.
Meperidine (Demerol) is not the preferred analgesic for use in breast-feeding women because of the long half-life of its metabolite in infants. Repeated exposure to analgesic agents, especially meperidine, may result in drug accumulation and toxic effects in young or compromised infants because of their underdeveloped hepatic conjugation.When possible, mothers should breast-feed their infants before taking the medication, and low to moderate dosages should be used.
CONTRACEPTIVE AGENTS
Hormones contained in combination oral contraceptive pills (OCPs) are not harmful to infants but, because estrogen diminishes the maternal milk supply, these products should be avoided in breast-feeding mothers whenever possible, especially during the first two months of breast-feeding. Progestin-only contraceptives are preferable, although these also may decrease milk supply. Delaying the use of OCPs, including the progestin-only mini-pill, until six weeks after starting breast-feeding and then using a progestin-only mini-pill (such as Micronor) will allow the mother to assess the drug's effect on her milk supply. If the medication is well-tolerated, repository medroxyprogesterone (Depo-Provera) can be used. When appropriate, the use of an intrauterine contraceptive device or other barrier method of birth control is ideal.
ANESTHETIC AGENTS
Although limited information is available regarding anesthetic agents and their compatibility with breast-feeding, use of propofol (Diprivan), thiopental sodium (Pentothal) and enflurane (Ethrane), should result in negligible amounts of drug exposure to the nursing infant. In general, the healthy term infant can safely nurse as soon after surgery as the mother is awake and alert.

Breast Awareness and Breast Diseases . Dr. Alaa Mosbah ,MD OBS and GYN

WHAT IS BREAST AWARENESS

-Breast awareness is a part of general body awareness. It is a process of getting to know your own breasts and becoming familiar with their appearance.

- Learning how your breasts feel at different times will help you to know what is normal for you. You can become familiar with your breast tissue by looking and feeling – in any way that is best for you(e.g. in the bath, shower, when dressing). Being breast aware and knowing what is normal for you will help you to be aware of any changes from normal .

THE NORMAL BREAST

Before the menopause

normal breasts feel different at different times of the month. The milk-producing tissue in the breast becomes active in the days before a period starts. In some women, the breast at this time feel tender and lumpy, especially near the armpits.

After a hysterectomy

the breasts usually show the same monthly differences until the time when your periods would have stopped.

After the menopause

activity in the milk-producing tissue stops. Normal breasts feel soft, less firm and not lumpy.

CHANGES TO LOOK OUT FOR

-Appearance

. Any change in the outline or shape of the breast, especially those caused by arm movements, or by lifting the breasts. Any puckering or dimpling of the skin.

-Feelings

. Discomfort or pain in one breast that is different from normal, particularly if new and persistent.

- Lumps. Any lumps, thickening or bumpy areas in one breast or armpit which seem to be different from the same part of the other breast and armpit. This is very important if new.

-Nipple change

. Nipple discharge, new for you and not milky

. Bleeding or moist reddish areas which don’t heal easily

. Any change in nipple position – pulled in or pointing differently

. A nipple rash on or around the nipple.

WHAT TO DO IF YOU FIND A CHANGE

-There can be many reasons for changes in the breast. Most of them are harmless but all of them need to be checked as there is a small chance they could be the first sign of cancer. If you are aware of any change in your breast from what is normal for you, tell your doctor without delay.
-Remember, you are not wasting anyone’s time. If there is a cancer present, the sooner it is reported, the more simple treatment is likely to be. This offers greater prospects of benefit in terms of quality of life.
-Breast cancer is very rare in women under the age of 40. The likelihood of developing breast cancer increases with age.

BREAST SCREENING

-If you are aged 50 and over it is strongly recommended that you take advantage of the National Health Service Breast Screening Programme which offers three-yearly mammography.
-This is an X-ray procedure which can detect breast changes at a very early stage. for more information about the Breast Screening Programme ask your doctor.
- Routine X-ray breast screening is not available for women under 50 as it has not been shown to be of benefit. If you have any cause for concern about your breasts tell your doctor.
BREAST AWARENESS
FIVE-POINT CODE

Know what is normal for you

• Look and feel

• Know what changes to look for

• Report any changes without delay

• Attend for breast screening if aged 50 or over

Anatomy of female breast:

-The breast lies between the 2nd and 6th ribs on the vertical axis and between the sternal edge and the midaxillary line on the horizontal axis. Breast tissue also projects into the lower axilla as the axillary tail.

-The breast is made up of the secretory glandular tissue and surrounding adipose tissue. The glandular tissue comprises between 15 and 20 lobes with varying numbers of ducts and lobules surrounded by connective tissue. Each lobe connects to a lactiferous duct, several of which converge to form a lactiferous sinus or milk chamber. These sinuses empty into the nipple where there are a number of duct openings. The nipple is surrounded by a pigmented area, the areola, which is lubricated by secretions from the sebaceous glands. Beneath the tissues of the breast lie the muscles of the chest wall and between the two is a layer of connective tissue known as the fascia.

Blood supply: the internal mammary artery, the axillary artery and the intercostal arteries

Lymph drainage:

is from superficial to deep

- The major drainage is then to the axilla and internal mammary chain.

- To lesser extent, lymph also drains by intercostal routes to nodes adjacent to vertebrae. The axillary nodes found below the level of the axillary vein are divided into 3 groups in relation to pectoralis minor muscle.

Level I lymph nodes: lateral to the lateral border of pectoralis minor .

Level II lymph nodes: behind pectoralis minor .

Level III lymph nodes: medial to the medial border of pectoralis minor Physiology of lactation: Lactation is inhibited during pregnancy by the action of estrogen on the hypoth. & pituitary. Inhibition is removed immediately after delivery ® PRL ® initiate lactation which is then maintained by suckling (nerve reflex via hypothalamus), PRL, GH & ACTH and ¯ Gonadotropins. Delivery of milk from the nipple is by contraction of myoepithelial cells around acini by the action of oxytocin secreted by neurohypophysis.

Breast diseases:

I- Bening breast problems:

A) Congenital abnormalities and development :

1- Supernumerary or accessory nipple

2- Supernumerary or accessory breast

3- Excessive breast enlargement

4- Hypoplasia or aplasia

5- Inversion of the nipples.

B) Breast pain (Mastalgia):

-Due to breast causes:

.Cyclic: premenstrual and relieved with the onset of menstruation. It may be unilateral or bilateral and radiate to axilla.
. Non cyclic: various causes as hormonal fluctuation, firm adenomas, duct ectasia, macrocysts and soreness in the pectoralis muscle from exertion or trauma

-Due to non – breast causes :

e.g. angioma, cholelithiasis, costochondritis, …..etc
Treatment:
1) Bromocriptine : Reduce PRL ® relief cyclic mastalgia, Dose: 2.5 mg twice daily
2) Danazol: Relief symptoms and reduce nodularity, Dose : 200 mg
3) Tamoxifen : Reduce breast pain, Dose 20 mg
4) Gammalenolenic acid ( GLA ): Dose 6- 8 capsules / day
5) Non medical measures: A well fitting brassier worn 24 hours / day, ¯ caffeine intake , regular exercise, phytoestrogen )

C)Nipple discharge:

Common, not all nipple discharge is pathologic

Types:

i) Physiologic:
. not associated with underlying breast disease, Bilateral, from multiple ducts and serous in character.
.Causes: exogenous estrogen and nipple stimulation Require no treatment.

ii) Galactorrhea: see hyperprolactinemia

iii) Pathologic discharge:
.Localized to a single duct and spontaneous. May be greenish , gray , serosangunous , serous or bloody
.Causes :Benign breast disease
.Investigation: mammography, biopsy from a mass

D) Duct ectasia:
. in women over 35 years.
.Presentation:
-Nipple discharge (from several ducts – cheesy in nature or with a palpable mass which may be hard or doughy)
-Nipple retraction
- Duct dilate & shorten (inspissated material )
Treatment: - formation - Antibiotics to avoid abscess Total duct excision with histological examination

E) Fibrocystic diseases:
-most common benign breast complaint in 10% of women < 21 years and more common in the premenopausal period. It produces bilateral pain and tenderness 7-10 days before menstruation
-General lines of Treatment: - Regular examination - OCS - NSI - Diuretic therapy - Avoid coffee, tea, chocolate and caffeinated soda
-Types:
.Fibroadenoma (breast mouse ):
It is the most common mass lesion < 25 years Palpable breast mass in upper outer quadrant, well circumscribed, firm, mobile discrete and may be multiple or bilateral Treatment: conservative or excision and biopsy. Needs careful follow up
.Breast cyst:
Common in perimenopausal age. Small discrete lump (fluctuant) Treatment: aspiration Galactocele: - During or after pregnancy or breast feeding - Contain breast milk Treatment: Aspiration (diagnostic and therapeutic)

II- Bening neoplastic lump:

1- Duct papilloma: rarely common. Treatment: may need excision of the duct

2- Lipoma: Treatment: excise only if suspicion of malignancy or if troublesome

III- Breast cancer:

What is the incidence of breast cancer?

-In 2006 there were 45,508 new registrations of breast cancer in women in the UK, and 314 in men.

-One in 9 women will develop breast cancer at some time in their life.

-The estimated risk of developing it for each of the other age groups has been calculated as:

Up to age 25, 1 in 15,000

Up to age 30, 1 in 1,900

Up to age 40, 1 in 200

Up to age 50, 1 in 50

Up to age 60, 1 in 23

Up to age 70, 1 in 15

Up to age 80, 1 in 11

Up to age 85, 1 in 10

-Age factors The incidence of breast cancer increases with age.
-Eighty per cent of cases occur in post-menopausal women. The risk of developing breast cancer continues to rise as women get older.
-Breast cancer is extremely rare in women in their teens or early twenties and uncommon in women under 35. After this age the risk begins to increase, rising sharply after the menopause.

-Breast cancer is the most common cancer in women worldwide.
-It accounts for about 25 per cent of all female malignancies and the proportion is higher in women in western, developed countries.

Incidence

-has been rising in many parts of the world, including the USA, Canada, Europe, the Nordic countries, Singapore and Japan.

-Over one million new cases occur each year worldwide.

-How many people die from breast cancer in the UK? 11,990 women and 92 men died from breast cancer in 2007

Survival

-The five-year survival rate for patients diagnosed 2001-2006 in England (period estimates) was 82 per cent.
-The stage at which a woman has breast cancer diagnosed greatly influences her survival chances.
-In general, the earlier the detection, the greater the chance of survival.

What are the causes of breast cancer?

- It is not clear exactly what causes breast cancer but it is thought that there are many risk factors, some already well established and some still being investigated.

-Age is strongly linked with breast cancer. The risk of breast cancer increases with age.

-Two breast cancer genes have been identified; BRCA1 and BRCA2. These genes have been found in approximately 85 per cent of families with four or more cases of breast cancer diagnosed under the age of 60. However, only about five per cent of all breast cancer cases (fewer than 2000 per year) are thought to be caused by breast cancer genes.

-There is a higher risk of breast cancer in the south of England and in Wales than in the north of the UK. The risk of breast cancer also appears to be higher in women from more affluent backgrounds. There is an increase in risk when people move from low risk to high risk countries. For example, Japanese immigrants to the USA increase their risk of breast cancer and acquire incidence rates similar to the American population within two generations. This suggests that risk may be linked to environmental and behavioural factors.

Risk Factors

Known risk factors for breast cancer are:

-being female

-increasing age

-previous history of breast cancer

-having proven benign breast disease in the past

-not breastfeeding long term

-current use of hormone replacement therapy or oral contraceptives

-having a family history of breast cancer

-having no children or few childrenhaving children at late ages (especially over 30)

-early puberty

-having a later menopause

-obesity (for post-menopausal women only)

-high consumption of alcohol

Breast cancer during or shortly after pregnancy :
- more worse than women with the same age and not pregnant which may be due to delay of the diagnosis and immunosuppressive effect of pregnancy.
-So, breast examination should be a part of prenatal examination, and mammography can be done if suspicion with the use of shield.
-Cancer breast diagnosed during pregnancy should be staged and treated in the same manner as in non pregnant.
Abnormal signs and symptoms:

1.Change in breast size, puckering , dimpling or retraction, thickening of skin or lump

2.Nipple discharge, retracted nipple, change in nipple position, Scaling around nipples

3.Pain or tenderness and redness

4.Sore on breast that does not heal

Screening of breast cancer:
-all women should be screened at the age 50 – 64 every 3 years with single oblique view mammography.
--In women with family history, mammography is routine before 50 years

Diagnosis:

1- Careful breast examination

2- Conventional mammography

3- Ultrasound

4- Fine needle aspiration or biopsy

5- Excision biopsy: the only definitive diagnosis Breast Cancer Screening : Two tests are commonly used by health care providers to screen for breast cancer:

-Mammogram
.A mammogram is an x-ray of the breast. This test may find tumors that are too small to feel. A mammogram may also find ductal carcinoma in situ, which may become invasive cancer in some women. .
.The ability of a mammogram to find breast cancer may depend on the size of the tumor, the density of the breast tissue, and the skill of the radiologist.
.Mammograms are less likely to find breast tumors in women younger than 50 years than in older women. This may be because younger women have denser breast tissue that appears white on a mammogram. A tumor also appears white on a mammogram, which makes it hard to find.

-Clinical breast exam (CBE)
A clinical breast exam is an exam of the breast by a doctor or other health professional. The doctor will carefully feel the breasts and under the arms for lumps or anything else that seems unusual.

Management:

·Breast surgery:

conservative lumpectomy with axillary dissection in combination with radiotherapy is as effective as mastectomy for local control in most cases.

· Tamoxifen:

prolongs disease – free interval.

· Chemotherapy:

has survival benefit in premenopausal women.

· Endocrine therapy:

-Aromatase inhibitors, LHRH analogues and ovarian ablation.
-Steroid receptor is best predictive

Follow up:

life long follow up is required

Subsequent contraception, pregnancy and HRT:
·Contraception: OCs is not recommended. Other alternative should be considered
· Pregnancy: subsequent pregnancy have no adverse effect. Patients are advised to wait 2 years before becoming pregnant.
·HRT: Tamoxifen is recommended if menopausal symptoms are severe.

EXAMPLE SCREENING ASSESSMENT PROTOCOL:

1. INTRODUCTION

1.1 Screening assessment is carried out to confirm (or otherwise) the presence of any significant breast abnormality identified at screening.
1.2 This is achieved by following the principles of triple assessment (imaging, clinical examination and needle biopsy) carried out by the screening assessment team.
1.3 All cases recalled are reviewed by the team immediately before the start of the assessment clinic to inform the team about what assessment procedures are required.
1.4 The reason for recall and the required diagnostic procedures should be discussed with each woman.
1.5 Whenever possible all of the necessary diagnostic procedures should be carried out at the first assessment clinic visit.
1.6 The imaging and clinical opinion should be recorded according to the following categories: • usually a 1–5 score (‘normal’ through to ‘definitely malignant’) • local categories vary but should be consistent and agreed by all the members of the clinical breast team.
Examples of categories are:
1. normal/definitely benign 1 normal
2. probably benign 2 benign
3. indeterminate 3 indeterminate
4. probably malignant 4 probably malignant
5. definitely malignant 5 definitely malignant.
1.7 All significant radiological and clinical abnormalities require needle biopsy.
1.8 Needle biopsy is reported according to the categories defined in Guidelines for Non-operative Diagnostic Procedures and Reporting in Breast Cancer Screening (NHSBSP Publication No 50, June 2001).
1.9 All women attending for assessment must be told of their assessment outcome and receive clear details of any further appointments and when and how they will receive their results before leaving the assessment clinic.
1.10 The results of all assessment investigations must be reviewed and a clear management decision made at the weekly multidisciplinary screening meeting held before the patient is seen again for results.
1.11 There should be only three possible outcomes after complete assessment: • no significant abnormality – return to normal screening • significant benign abnormality requiring surgery (eg Phyllodes tumour) • diagnosis of cancer.
1.12 All women attending for assessment and their GP must receive written confirmation of the outcome.
2. IMAGING
2.1 The majority of women recalled for assessment have a mammographic abnormality. Further mammography and/or ultrasound are performed to determine if this is significant.
2.2 The imaging assessment performed will depend on the type of lesion being assessed. See Clinical Guidelines for Breast Cancer Screening Assessment (NHSBSP Publication No 49, 2nd edition, January 2005). 2.3 The imaging opinion (based on both mammography and ultrasound findings) is classified according to the categories 1–5 defined in paragraph 1.6 above.
2.4 Abnormalities not visible on ultrasound should be managed on the basis of their mammographic and clinical features. Clinical abnormalities with no imaging correlate must be managed on the basis of their clinical features. Needle biopsy should be on the basis of the most suspicious imaging or clinical feature.
2.5 For suspicious microcalcifications, core biopsy must be performed and specimen radiography used to confirm satisfactory sampling.
2.6 Cysts should be aspirated if there is any doubt about their nature.
3. CLINICAL ASSESSMENT
3.1 Clinical examination is mandatory for all women recalled for assessment of significant symptoms and/or signs whether or not the screening mammogram is normal.
3.2 Clinical assessment must also be performed when a significant radiological lesion is confirmed and before any needle biopsy.
3.3 Clinical examination may not be necessary for women who are shown to be entirely normal after further imaging.
3.4 When a significant clinical abnormality has been found, the team should be certain that there is radiological clinical concordance.

Mammographic/ultrasound abnormality and clinical abnormality.
If there is a discordance in the site of the abnormality, review of mammogram and ultrasound of the clinical abnormality should be performed together by the radiologist and the clinician. Clinical needle biopsy in addition to imaging needle biopsy must be performed if the site of the significant clinical abnormality does not correspond with the imaging abnormality. Mammogram normal with clinical abnormality. Ultrasound of the abnormal clinical site may be useful particularly in the dense breast (eg cysts found on ultrasound may be aspirated). When imaging is normal in the presence of clinical abnormality, then a freehand needle biopsy of the abnormality should be considered.
4. TRIPLE ASSESSMENT
4.1 The clinical and radiological opinions are used independently to decide on the significance of any abnormality.
4.2 The clinical and radiological opinions are formally documented before any further intervention (eg needle biopsy).
4.3 The most suspicious opinion prevails. If the radiological opinion is that the abnormality is ‘probably malignant’ and the surgical opinion is that there is ‘no significant abnormality’ then the woman is managed on the basis of the radiological opinion. Similarly, if there is a clinically suspicious lesion and imaging is normal, the patient is managed on the basis of the clinical opinion.
4.4 The clinical opinion may not downgrade the imaging opinion or vice versa.
4.5 The need for needle biopsy is decided by the prevailing opinion: • needle biopsy is not required for lesions classified as normal or definitely benign • needle biopsy is mandatory for all abnormalities classified as probably benign or more suspicious.
4.6 All needle biopsy results must be discussed in the context of the imaging and clinical finding at the multidisciplinary screening assessment meetings. Needle biopsy result not consistent with the clinical/imaging opinion must be discussed fully and a clear management decision reached at this meeting to ensure that either false negative or false positive results are managed appropriately.
5. IMAGING/CLINICAL CATEGORIES
The categories listed may vary from unit to unit. For example, it is common for the ‘normal’ and ‘definitely benign’ categories to be listed separately.
Normal/definitely benign

5.1 The patient can be reassured and discharged (eg normal mammography, ultrasound and clinical examination). Needle biopsy is not required.
Probably benign

5.2 This category applies when there is normal imaging but with clinical abnormality that is almost certainly benign (eg a prominent area of ‘thickening’ that is normal on imaging).
5.3 Although the risk of malignancy is low (less than 5%), needle biopsy is required for all cases classified as ‘probably benign’.
5.4 A result of ‘inadequate/benign’ on fine needle aspiration (FNA) or ‘normal breast tissue/benign breast tissue’ on core biopsy is acceptable. 5.5 With any of these outcomes the woman can be advised that further procedures or surgical biopsy are not required.
5.6 With any other diagnosis (C3–C5; B3–B5), a repeat core biopsy should be performed before surgical biopsy.
5.7 For C5 or B5 results, definitive therapeutic surgery, especially mastectomy, should only take place after careful re-evaluation in light of the low clinical and imaging suspicions of malignancy. Indeterminate/probably benign
5.8 This classification applies to abnormalities that have benign features on either imaging or clinical assessment, but a definitive cytological or histological diagnosis of a benign lesion is required to avoid excision biopsy (eg a clinically smooth and mobile 1 cm lump with benign imaging features that is most likely to represent a fibroadenoma).
5.9 The risk of malignancy is 5 to 50%. FNA must show a good yield of unequivocally benign epithelial cells and core biopsy must provide a benign diagnosis consistent with the clinical and imaging findings – ‘normal breast tissue’ (B1) should not be accepted as representative when the patient has a discrete lump with a provisional diagnosis of a fibroadenoma.
5.10 An ‘inadequate’ FNA (C1) or ‘normal’ core biopsy (B1) is not acceptable and, along with an ‘equivocal’ (C3 or B3) and ‘suspicious’ (C4 or B4) result, requires repeat sampling. If FNA cytology was performed initially, the repeat procedure is usually performed as a core biopsy.
5.11 With a ‘malignant’ result (C5 or B5), definitive surgical excision can be planned. Repeat needle biopsy may be considered necessary before performing mastectomy. Probably malignant
5.12 This classification is used when there is a strong clinical or imaging suspicion of malignancy (50 to 90%) but the features are not sufficiently characteristic to classify as definitely malignant (eg an area of architectural distortion).
5.13 Therapeutic surgery can be performed if needle biopsy shows unequivocal evidence of malignancy (C5 or B5).
5.14 For all other needle biopsy results (C1–C4 or B1–B4), a diagnostic open surgical biopsy should be performed if repeat sampling fails to provide a definitive diagnosis of cancer (C5 or B5). If FNA cytology was performed initially, the repeat procedure is usually performed as a core biopsy.
Malignant

5.15 This classification is given when there are unequivocal clinical or imaging signs of malignancy.
5.16 Needle biopsy is performed to obtain a definitive non-operative diagnosis and allow for counselling for therapeutic surgery.
5.17 For all other needle biopsy results (C1–C4 or B1–B4), a diagnostic open surgical biopsy should be performed if repeat sampling fails to provide a definitive diagnosis of cancer (C5 or B5). If FNA cytology was performed initially, the repeat procedure is usually performed as a core biopsy.
6. SHORT-TERM RECALL
6.1 Properly applied, the assessment procedure should result in a definitive result from which either the woman is discharged back to normal screening or referred for treatment.
6.2 Short-term recall should only be recommended when needle biopsy is not possible and the risk of malignancy is low, or when the woman refuses to undergo either needle biopsy or diagnostic surgery.
6.3 This outcome should only be decided after attendance at an assessment clinic and/or full discussion at the multidisciplinary screening assessment meeting.
6.4 Women placed on short-term recall should have the reasons fully explained in the presence of the nurse specialist.
6.5 The short-term recall attendance should be to the assessment clinic. 6.6 No woman should be placed on short-term recall more than once in each screening round.
7. MANAGING THE NEEDLE BIOPSY RESULT
7.1 A pathological result of C1/B1 is acceptable when needle biopsy has been performed for a category 2 (probably benign) imaging/clinical opinion.
7.2 A result of C2/B2 is required for all category 3 (indeterminate) lesions before the woman can be discharged back to normal screening. 7.3 For microcalcifications, specimen radiography of the core specimens should be performed and must demonstrate representative microcalcification. In the absence of representative calcification, the presence of histological calcification should not be accepted as indicating that a representative sample has been obtained. In these circumstances, the core biopsy should be repeated or open surgical biopsy performed. 7.4 A diagnosis of atypical ductal hyperplasia (ADH) on needle biopsy necessitates surgical excision to definitively exclude ductal carcinoma in situ (DCIS) in the adjacent tissue.
7.5 A diagnosis of radial scar or complex sclerosing lesion with no evidence of epithelial atypia can be managed by offering the patient a choice of either wider sampling with vacuum assisted mammotomy or diagnostic surgical excision. The presence of epithelial atypia in association with a radial scar or complex sclerosing lesion necessitates surgical excision to definitively exclude associated malignant change.
7.6 A C5 or B5 result is required before definitive therapeutic surgery can take place. 7.7 C3, C4, B3 and B4 results should result in a repeat needle biopsy (preferably core biopsy or vacuum assisted mammotomy) or open surgical biopsy to obtain a definitive result.

Screening for Breast Cancer , November 2009

U.S. Preventive Services Task Force (USPSTF)
Rationale
Importance
-Breast cancer is the second-leading cause of cancer death among women in the United States.
-Widespread use of screening, along with treatment advances in recent years, have been credited with significant reductions in breast cancer mortality.
Detection
Mammography, as well as physical examination of the breasts (CBE and BSE), can detect presymptomatic breast cancer. Because of its demonstrated effectiveness in randomized, controlled trials of screening, film mammography is the standard for detecting breast cancer; in 2002, the USPSTF found convincing evidence of its adequate sensitivity and specificity.
Benefits of Detection and Early Intervention
-There is convincing evidence that screening with film mammography reduces breast cancer mortality, with a greater absolute reduction for women aged 50 to 74 years than for women aged 40 to 49 years. The strongest evidence for the greatest benefit is among women aged 60 to 69 years.
-Among women 75 years or older, evidence of benefits of mammography is lacking.
-Adequate evidence suggests that teaching BSE does not reduce breast cancer mortality.
-The evidence for additional effects of CBE beyond mammography on breast cancer mortality is inadequate.
-The evidence for benefits of digital mammography and MRI of the breast, as a substitute for film mammography, is also lacking.
Harms of Detection and Early Intervention
-The harms resulting from screening for breast cancer include psychological harms, unnecessary imaging tests and biopsies in women without cancer, and inconvenience due to false-positive screening results. Furthermore, one must also consider the harms associated with treatment of cancer that would not become clinically apparent during a woman's lifetime (overdiagnosis), as well as the harms of unnecessary earlier treatment of breast cancer that would have become clinically apparent but would not have shortened a woman's life. Radiation exposure (from radiologic tests), although a minor concern, is also a consideration.
-Adequate evidence suggests that the overall harms associated with mammography are moderate for every age group considered, although the main components of the harms shift over time. Although false-positive test results, overdiagnosis, and unnecessary earlier treatment are problems for all age groups, false-positive results are more common for women aged 40 to 49 years, whereas overdiagnosis is a greater concern for women in the older age groups.
-There is adequate evidence that teaching BSE is associated with harms that are at least small. There is inadequate evidence concerning harms of CBE.
USPSTF Assessment
The USPSTF has reached the following conclusions:
-For biennial screening mammography in women aged 40 to 49 years, there is moderate certainty that the net benefit is small. Although the USPSTF recognizes that the benefit of screening seems equivalent for women aged 40 to 49 years and 50 to 59 years, the incidence of breast cancer and the consequences differ. The USPSTF emphasizes the adverse consequences for most women—who will not develop breast cancer—and therefore use the number needed to screen to save 1 life as its metric. By this metric, the USPSTF concludes that there is moderate evidence that the net benefit is small for women aged 40 to 49 years.
-For biennial screening mammography in women aged 50 to 74 years, there is moderate certainty that the net benefit is moderate.
-For screening mammography in women 75 years or older, evidence is lacking and the balance of benefits and harms cannot be determined.
-For the teaching of BSE, there is moderate certainty that the harms outweigh the benefits.
-For CBE as a supplement to mammography, evidence is lacking and the balance of benefits and harms cannot be determined.
-For digital mammography and MRI as a replacement for mammography, the evidence is lacking and the balance of benefits and harms cannot be determined.

Clinical Considerations
Patient Population Under Consideration
This recommendation statement applies to women 40 years or older who are not at increased risk for breast cancer by virtue of a known underlying genetic mutation or a history of chest radiation.
Assessment of Risk
Increasing age is the most important risk factor for breast cancer for most women. Women without known deleterious genetic mutations (such as BRCA1 or BRCA2) may still have other demographic, physical, or historical risk factors for breast cancer, but none conveys a clinically important absolute increased risk for cancer.
Screening Tests
-In recent decades, the early detection of breast cancer has been accomplished by physical examination by a clinician (CBE), by a woman herself (BSE), or by mammography.
-Standardization of mammography practices enacted by the
Mammography Quality Standards Act have led to improved mammography quality.
Screening Intervals
In trials that demonstrated the effectiveness of mammography in decreasing breast cancer mortality, screening was performed every 12 to 33 months. The evidence reviewed by the USPSTF indicates that a large proportion of the benefit of screening mammography is maintained by biennial screening, and changing from annual to biennial screening is likely to reduce the harms of mammography screening by nearly half. At the same time, benefit may be reduced when extending the interval beyond 24 months; therefore the USPSTF recommends biennial screening.
Treatment
-Effective treatments, including radiation, chemotherapy (including hormonal treatment), and surgery, are available for invasive carcinoma.
-Although the standard treatments women receive for ductal carcinoma in situ (DCIS) include surgical approaches as well as radiation and hormonal therapy, considerable debate exists about the optimal treatment strategy for this condition.
Considerations for Practice Regarding I Statements
Clinical Breast Examination
-Potential Preventable Burden. The evidence for CBE, although indirect, suggests that CBE may detect a substantial proportion of cases of cancer if it is the only screening test available. In parts of the world where mammography is infeasible or unavailable (such as India), CBE is being investigated in this way.
-Potential Harms. The potential harms of CBE are thought to be small but include false-positive test results, which lead to anxiety and breast cancer worry, as well as repeated visits and unwarranted imaging and biopsies.
-Costs. The principal cost of CBE is the opportunity cost incurred by clinicians in the patient encounter.
-Current Practice. Surveys suggest that the CBE technique used in the United States currently lacks a standard approach and reporting standards. Clinicians who are committed to spending the time on CBE would benefit their patients by considering the evidence in favor of a structured, standardized examination .
Digital Mammography
-Potential Preventable Burden. Digital mammography detects some cases of cancer not identified by film mammography; film mammography detects some cases of cancer not identified by digital mammography. Overall detection is similar for many women. For women who are younger than 50 years or have dense breast tissue, overall detection is somewhat higher with digital mammography. It is not clear whether this additional detection would lead to reduced mortality from breast cancer.
-Potential Harms. The possibility of false-positive test results is similar for film and digital mammography. It is uncertain whether overdiagnosis occurs more with digital mammography than with film mammography.
-Costs. Digital mammography is more expensive than film mammography.
-Current Practice. Some clinical practices are now switching their mammography equipment from film to digital. This may curtail the availability of film mammography in some areas.
Magnetic Resonance Imaging
-Potential Preventable Burden. Studies of the use of contrast-enhanced MRI for breast cancer screening have been conducted only in very high-risk populations. In these studies, MRI detected more cases of cancer than did mammography. It is unknown whether detecting these additional cases of cancer would lead to reduced breast cancer mortality.
-Potential Harms. Contrast-enhanced MRI requires the injection of contrast material. Studies of MRI screening have shown that MRI yields many more false-positive results than does mammography. Magnetic resonance imaging has the potential to be associated with a greater degree of overdiagnosis than mammography.
-Costs. Magnetic resonance imaging is much more expensive than either film or digital mammography.
Current Practice. Magnetic resonance imaging is not currently used for screening women at average risk for breast cancer.
Screening Mammography in Women 75 Years or Older
-Potential Preventable Burden. No women 75 years or older have been included in the multiple randomized clinical trials of breast cancer screening. Breast cancer is a leading cause of death in older women, which might suggest that the benefits of screening could be important at this age. However, 3 facts suggest that benefits from screening would probably be smaller for this age group than for women aged 60 to 69 years and probably decrease with increasing age: 1) the benefits of screening occur only several years after the actual screening test, whereas the percentage of women who survive long enough to benefit decreases with age; 2) a higher percentage of the type of breast cancer detected in this age group is the more easily treated estrogen receptor-positive type; and 3) women of this age are at much greater risk for dying of other conditions that would not be affected by breast cancer screening.
-Potential Harms. Screening detects not only cancer that could lead to a woman's death but also cancer that will not shorten a woman's life. Women cannot benefit from—but can be harmed by—the discovery and treatment of this second type of cancer, which includes both cancer that might some day become clinically apparent and cancer that never will. Detection of cancer that would never have become clinically apparent is called overdiagnosis, and it is usually followed by overtreatment. Because of a shortened life span among women 75 years or older, the probability of overdiagnosis and unnecessary earlier treatment increases dramatically after about age 70 or 75 years. Overdiagnosis and unnecessary earlier treatment are important potential harms from screening women in this age group.
-Current Practice. Studies show that many women 75 years or older are currently being screened.
Useful Resources
Other USPSTF recommendations on screening for genetic susceptibility for breast cancer and chemoprevention of breast cancer are available on the Agency for Healthcare Research and Quality Web site(http://www.preventiveservices.ahrq.gov).
Other Considerations
Implementation
The Task Force on Community Preventive Services has reviewed the evidence on methods to increase breast cancer screening, including reminder systems and other interventions .
Explanation of Change in Recommendation
The 2002 USPSTF issued a B recommendation for screening mammography for women 40 years or older. However, it went on to say:
The precise age at which the benefits from screening mammography justify the potential harms is a subjective judgment and should take into account patient preferences. Clinicians should inform women about the potential benefits (reduced chance of dying from breast cancer), potential harms (for example, false-positive results, unnecessary biopsies), and limitations of the test that apply to women their age. Clinicians should tell women that the balance of benefits and potential harms of mammography improves with increasing age for women between the ages of 40 and 70 .
The updated USPSTF recommendation endorses this approach to deciding when to start screening. However, the current USPSTF is now further informed by a new systematic review ,which incorporates a new randomized, controlled trial that estimates the "number needed to invite for screening to extend one woman's life" as 1904 for women aged 40 to 49 years and 1339 for women aged 50 to 59 years. Although the relative risk reduction is nearly identical (15% and 14%) for these 2 age groups, the risk for breast cancer increases steeply with age starting at age 40 years. Thus, the absolute risk reduction from screening (as shown by the number needed to invite to screen) is greater for women aged 50 to 59 years than for those aged 40 to 49 years.
The current USPSTF statement is also informed by the Cancer Intervention and Surveillance Modeling Network (CISNET) modeling studies that accompany this recommendation. The Task Force considered both "mortality" and "life-years gained" outcomes. In this case, given that the age groups (40 to 49 years and 50 to 59 years) are adjacent, the Task Force elected to emphasize the mortality outcomes from the modeling studies. Of the 8 screening strategies found most efficient, 6 start at age 50 years rather than age 40 years. The frontier curves for the mortality outcome show only small gains but larger numbers of mammograms required when screening is started at age 40 years versus age 50 years.
In conclusion, the USPSTF reasoned that the additional benefit gained by starting screening at age 40 years rather than at age 50 years is small, and that moderate harms from screening remain at any age. This leads to the C recommendation. The USPSTF notes that a "C" grade is a recommendation against routine screening of women aged 40 to 49 years. The Task Force encourages individualized, informed decision making about when to start mammography screening

Summary of Recommendation and Evidence :
-The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. Grade: B recommendation.
-The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. Grade: C recommendation.
-The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. Grade: I Statement.
-The USPSTF recommends against teaching breast self-examination (BSE).Grade: D recommendation.
-The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. Grade: I Statement.
-The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. Grade: I Statement.

Shoulder dystocia . Dr. Alaa Mosbah , M.D OBS & GYN

Definition:

-Shoulder dystocia is the inability to deliver the fetal shoulders after delivery of the head, without the aid of specific maneuvers .

-Prolonged head-to-body expulsion time , > 60 seconds .

Incidence:

Reported to occur in 0.2-2% of births

Risk factors:

A) Antepartum risk factors:

1- Fetal macrosomia 2- Maternal obesity

3- Diabetes mellitus 4- Post-term pregnancy

5- Male gender 6- Advanced maternal age

7- Excessive maternal weight gain

8- Prior shoulder dystocia

9- Prior macrosomic infant

10- Contracted pelvis and platypelloid pelvis

B) Intrapartum risk factors:

1- 1st stage of labour abnormalities as protraction disorders and arrest disorders

2- Prolonged 2nd stage of labour

3- Oxytocin administration

4- Mid-forceps and mid-vacuum extraction

Remember :

-Many cases of shoulder dystocia occur with no readily identified risk factors!!!!

-Shoulder dystocia with neonatal injury occurs in about 0.4 to 3 vaginal births per 1000

- Medical liability payouts for a baby with subsequent disability average around $500,000

Causes:

1. Large shoulders which may be due to :

- Maternal obesity.

- Diabetic mothers.

- Post-term pregnancy.

- Anencephaly.

2. Failure of shoulder rotation.

3. Contracted and platypelloid pelvis.

Degrees:

1- Severe (bilateral): both posterior & the anterior shoulders do not cross the pelvic brim.

2- Mild (unilateral): the posterior shoulder enters the pelvic cavity, while the anterior shoulder hooked behind the S. pubis

Diagnosis :

-Shoulder dystocia should be anticipated in women with risk factors

-Various sonographic parameters to evaluate a macrosomic fetus (fetal weight > 4 kg)

-During labour, protracted cervical dilatation, prolonged second stage or difficult midforceps.

- The head is delivered and the chin is applied firmly against the perineum.

- There is no further progress in spite of gentle traction on the head.

-Congestion of the face and difficult vaginal examination .

Complications:

A) Fetal complications:

increase mortality and morbidity

1) Brachial plexus injuries :

.Strain or stretch ,

.Partial disruption ,

.Complete avulsion

-Injury primarily to lateral trunk (C5,6, 7) leads to Erb’s palsy – adducted shoulder, extended elbow, and flexed wrist (“waiter’s tip”)

-Injury primarily to the medial trunk (C8, T1) leads to Klumpke’s palsy – paralyzed hand with good shoulder and elbow function

2) Fracture clavicle or humerus.

3) Asphyxia and death.

B) Maternal complications :

· Increase blood loss

· Uterine rupture

· Extensive vaginal lacerations and cervical tears

Management:

(A) Prophylaxis:

1. Proper antenatal care particularly for high risk mothers as diabetics.

2. Antepartum assessment of foetal weight---- macrosomic babies should be delivered by caesarean section.

(B) Management of shoulder dystocia:

Calling urgently an anaesthetist and paediatrician.

The following methods are used in a rapid succession when the previous one failed:

(1) Generous episiotomy + gentle downward traction + suprapubic pressure by an assistant obliquely to

flex the anterior shoulder against the foetal chest.

(2) Mc Roberts' manoeuvre: It is sharp flexion of the maternal thighs against her abdomen. This can free the shoulders by:

i- backward displacement of the sacral promontory.

ii- upward displacement of the symphysis pubis.

iii- Decrease the inclination of the pelvic inlet.

iv- Decrease in lumbar lordosis.

(3) Rotation of the anterior shoulder : by applying pressure on the posterior aspect of the impacted anterior shoulder to move it from the anteroposterior to the oblique diameter of the pelvic inlet.

(4) Woods screw manoeuvre:

Woods (1943) described this manoeuvre to rotate the foetus as a screw between the resisted promontory and symphysis.

-Two fingers of the right hand is pressing from the posterior aspect of the posterior shoulder to rotate it 180 anteriorly where it escapes from below the symphysis.

-The left hand is placed on the mother’s abdomen and assists this rotation by pressing on the foetal buttock in the same direction of rotation.

(5) Extraction of the posterior arm: by pressing with 2 fingers against the cubital fossa to sweep the

posterior arm in front of the chest and deliver it giving space for the anterior shoulder to escape from below the symphysis.This is aided by suprapubic pressure.

(6) Zavanelli manoeuvre (cephalic replacement):

1. Prepare for caesarean section.

2. Subcutaneous terbutaline (tocolytic) is given to relax the uterus.

3.Rotate the head manually to the antero-posterior diameter (pre-restitution position).

4. Flex the head and press on it firmly and constantly to replace it intravaginally where it is supported by an assistant.

5. Immediate caesarean section is performed.

(7) Clavicular fracture:

was described to reduce the diameter of the shoulders. It is done by upward pressure against its

midportion to avoid injury of the subclavian vessels.

(8) Cleidotomy:

It is cutting of the clavicle and usually reserved for a dead foetus.

(9) Symphysiotomy:

It is advocated by some authors to overcome contracted pelvis in women living in uncivilised areas.

(10)The all four maneuver .

-ACOG Guidelines 2002 :

1. Most cases of shoulder dystocia can not be predicted or prevented because there are no accurate methods for identifying which fetus will develop this complication.

2. Ultrasonic measurements to estimate macrosomia have limited accuracy

3. Planned cesarean section based on suspected macrosomia was not a reasonable strategy for most women

4. Planned cesarean section may be reasonable for the nondiabetic woman with an estimated fetal weight exceeding 5000 g or the diabetic whose fetus is estimated over 4500 g

Pelvic Inflammatory Disease( PID) , Dr. Alaa Mosbah ,MD OBS and GYN

Definition:
PID is defined as acute clinical syndrome associated with ascending spread of microorganism from the vagina or cx to the endometrium fallopian tube / or contiguous structures but not related to (pregnancy or surgery). By other mean, it refers to infection resulting from sexual activity and excludes that due to childbirth, surgery or T.B.
A more descriptive and accurate term is salpingitis or salpingoophritis

Epidimiology:
1- An accurate incidence is difficult to determine because there is no diagnostic test which is simple, safe and specific and also the patient may be a symptomatic or run a very benign clinical course.
2- The highest incidence is among sexually active women in their teenage years. So it is strongly correlated with prevalence of STD
3- The incidence in developing world is more difficult to assess and the high incidence of STD in many African countries can be attributed to
· High proportion of teenagers
· Early sexual practice and multiple sex. Partners
· Delay in ttt of STD
· Female circumcision
4- Chlamydia and N. gonorrhea are the most prevalent S.T. bacteria in western world (implicated in 60% of PID in young women)
5- In U.K., uncomplicated gonococcal infection is halved in frequency in last decade while chlamydia continued to rise

Risk factors:
[1]. Age:
with young age (15 – 20y.) due to :
· sexual activity in young age
· Col. Cell ectopy susceptible to chlamydial infection and gonococcal infection
the risk is unlikely after 30y.
[2]. Parity: with nulliparity
[3]. Race: pressure in black due to low socioeconomic status
[4]. Douching:pressure in the vagina forcing material up through the cx.
[5].Cigarette smoking: risk due to:
· Damage of immune system
· Alteration of bl. supply to f.t.
[6]. Previous episodes of acute acute salpingitis: previously damaged tube is susceptible to altered defense mechanism
[7]. Sexual intercourse: pressure gradient bet. lower and upper genital T. cervical barrier compromisation
[8].Multiple sexual partner
risk of meeting male with STD.
[9]. Use of IUD: highest risk in 20 days following menstruation ¯ thereafter. IUD strings facilitates access of vaginal bacteria

Contraception and PID
· IUD: risk
· Barrier contraception: ¯ STD and hence PID
· O.Cs : ¯ risk due to:
- thick cervical mucus
- atrophy of endomet.
- ¯ menstrual bl. loss
· Sterilisation: incidence is very rare and is confined to the stump of the tube that remain attached to the uterus

Microbiology of PID:
· Cervical culture do not reflect the microbiology tube infection
· Culture obtained by culdecentesis correlates with tube exudate culture
· Endometrial culture obtained by swab or biopsy correlate best with culture obtained by swab or biopsy correlate best with culture of tubal exudate
1- Sexually transmitted pathogens: (young women – recent infection)
N. gonorrhea is most common in 3rd world and north America chlamydia trachomatis is more likely to cause mild or subclinical infection serious tubal damage results from sites infection as from clinically apparent salpingitis
2- Aerobic and anaerobic organisms:
most commonly recovered from
- older women
- recurrent cases
- long standing cases
· Aerobes: gm –ve as E coli
gm +ve as streptococcus viridans, enterococci
· Anaerobes: peptococci, peptostreptococci and bacteroides
Anaerobes are present in very severe disease often as mixed with aerobes
3- Mycoplasma hominis and ureaplasma urealyticum:
cause parametritis rather than salpingitis
4- Actinomyces israeli:
- Common with IUD
- High rate of abscess formation
5- True viruses: Coxsachie virus, Echo, Herpes simplex virus type II

Pathogenesis:
Most cases fall into 2 groups;
1-Those due to sexually transmitted organisms: found in young adults & nulliparous women.
2-Those due to endogenous vaginal or large bowel organisms which are associated with B.V organisms. It occurs in older women & in parous women.

Any organism from lower genital tract has to pass the uterine cervix to gain access to the endometrium and fallopian tube.
In young nullipara, there is competent anatomical, physiological, biochemical and immunological barrier. With increasing age & trauma of childbirth or surgery, this barrier is less effective.

How pathogens pass this barrier in young nullipara?
1- Adherence to spermatozoa
2- In suck due to pressure gradient of coitus and subsequent uterine activity
3- Menstruation
4- Surgical intervention
5- IUD

· In gonococcal salpingitis:
Spread is direct canalicular from endocx along endomet. surface to the tubal mucosa leading to endosalpingitis
70% occur at the end or just after the menstrual period. This is attributed to:
- Loss of cervical mucus plug.
- Sloughing of endomet.
- Menstrual blood (good culture medium)
- Uterine contractions during menses
® retrograde menstruation

· In non – gonococcal salpingitis:
Usually polymicrobial and include
- aerobic
- anaerobic
- chlamydia
- mycoplasma
- possibly viral agents

· Chlamydia: spread as gonococcus
· Mycoplasma: reach the adnexa by lymphatic spread via the parametrial tissue and broad ligament ® parasalpingitis and parametritis
· Other organisms: a critical number of organisms in the cervix is needed to overcome local host defense mechanism in the cervix, so allowing infection to ascend.
B.V organisms are associated with high colony count of anaerobic bacteria.

· In IUD associated salpingitis
Most infection occur at time of insertion
- break sterile technique
- introduction of pathogenic org.
Infection 5 fold
After that infection is due to
- IUD strings act as wick for org.
- IUD act as f.t. that interfere with local host defense
There is of adnexal abscess which is usually unilateral
Pathology:
In mild PID;
· The pelvic organs are much affected
· The serosal surfaces of f.t. appear reddened and hyperemic
· The tubes are edematous but freely mobile with patent abdominal ostia
· The may be sticky, purulent exudate on the serosal surfaces of the pelvic organs and exuding from the fimbrial end of the tube

In moderate PID;
· Inflammation and oedema of f.t. is more pronounced
· Tubal mobility may be limited
· Patchy fibrin deposits are seen on the serosal surfaces and loose adhesions may from between the pelvic and abdominal viscera
· The distal end of f.t. often appear phimotic and the tubes may not be patent

In severe PID;
· Occlusion of tubal ostia as a result of the fimbria sticking together resulting in pyosalpinx
· Marked distortion of pelvic anatomy
· Pelvic peritoneum is severely damaged (congested) and the pelvic organs become adherent resulting in the formation of complex inflammatory mass
· If the infectious process has not been sealed off in the f.t., then a tuboovarian abscess, the most severe manifestation of PID may develop. it is likely that development of TOA is the natural progression when PID is not arrested by either host’s natural defense or by medical ttt

- The extent of damage of tubal function varies often an episode of PID
· At best: in mild disease, there will be complete resolution of tubal morphology with no effect on function
· At worst: distal tubal occlusion with hydrosalpinx formation, intrluminal fibrosis and damage to tubal mucosa and cilia ® irreversible impairment of function

- Fitz – Hugh Curtis syndrome (FHCS):
is an extrapelvic manifestation of PID and is composed of 2 phases
· Acute phase: perihepatitis and focal peritonitis that result from transport of inflammatory peritoneal fluid either directly or by lymphatic to the subphrenic and subdiaphragmatic space
Both N G and C. trachomatis are isolated from liver surface in FHCS
M/E: of liver parenchyma reveals on acute infl. of liver capsule without involvement of parenchyma
Liver function: are normal
· Chronic phase: is characterized by adhesions bet. the ant. surface of the liver and the ant. abdominal wall

- The organisms spectrum in PID:
· Chlamydia, mycoplasma ®mild or subclinical disease
· N. gonorrhea ® moderate disease
· Anaerobes ® severe disease with abscess formation

Chronic sequelae of PID:
1- Infertility: 15% after one attack
35% after 2 attack
65% after 3 attack
2- Ectopic preg. : 8%
3- Recurrent PID: 25%
4- Chronic pelvic pain

Diagnosis of PID:
(I) Clinical : diagnosis of acute salpingitis is accurate in only 65% the other diagnosis will be:
- normal findings: 25%
- acute appendicitis
10% - endometriosis
- ruptured cyst
- ectopic preg

Hager criteria : 1983
a) Major criteria: all must be present
1- Lower abdominal pain
2- Cervical mobility tenderness
3- Adnexal tenderness
4- Negative serum hCG by RIA
5- Pelvic ultrasound not suggestive of an alternate diagnosis

b) Minor criteria: one must be present
1- Oral temp. > 38°c
2- Leucocytosis > 10,000/mm3
3- Culdecentesis yielding WBCs / bacteria
4- ESR > 15mm/hr or CRP > 30mg/l
5- Presence of inflammatory mass noted on pelvic ex. or pelvic U/S gm stain or +ve culture from endocx suggestive of N.G or +ve culture or monoclonal antibody directed smear for chlamydia

(II) Laboratory investigations: to detect organisms or evidence of their presence (antibodies)
1- Gram stain and cervical culture for gonococci.
2- High vaginal swab for trichomonas vaginalis
3- gm stain for B.V.
4- ELISA or culture from the cx for chlamydia
5- Uretheral, rectal or oral cultures for gonococci
6- Serologic test for $, hepatitis B and C, HIV as the patient with one STD is at risk for other infection

(III) Laparoscopic diagnosis: gold standard as s & s are not specific
Jacobson and Westrom 1969
· Pronounced hyperemia of tubal surface
· Oedema of tubal wall
· A sticky exudate on tubal surface and from tubal ends when patent
Diagnostic accuracy is enhanced by (BHCG – U/S).

Modification of these criteria by Hager 1983 for assessment of severity
a- Mild disease: tubal erythema and oedema, expression of exudate from tube
b- Moderate disease: gross purulent material, tubes are patent
c- Severe disease: Tuboovarian abscess, pyosalpinx, pelvic abscess

Also, laparoscopy can assess the chronicity
a- Acute disease
· Normal fimbriae with no adhesions
· Purulent exudate from fimbrial end
b- Subacute disease
· Gelatinous adhesions with or without pyosalpinx or abscess
· Pelvic peritonitis with bowel adhesions and abundant purulent exudate
c- Chronic or recurrent disease: with dense fibrous adhesions presence of adhesions and hydrosalpinx ® difficult to determine if there is an acute infection. However, presence of exudate (purulent) does not indicate active infection
Oedema and hyperemia does not indicate active infection

Treatment of PID
Principles
· The goal of therapy in uncomplicated acute salpingitis is:
1- Prevention of infertility
2- Prevention of ectopic preg
3- Prevention of tubo-ovarian abscess
· The goal of the therapy in salpingitis complicated by abscess is
1- Preservation of life
2- Prevention of septic complications
· As PID is polymicrobial, antibiotic coverage should include:
1- Chlamydia
2- N.G
3- Anaerobes
4- gm +ve and gm –ve aerobes

Regimens: acc. to severity, it may be outpatient or inpatient regimens
(A) Outpatient regimen: if symptoms and signs are mild
Cefoxitin 2gm I.M
Or Amoxycillin 3gm oral
Or Ampicillin 3.5gm oral
Or Aqueous procaine penicillin G 4.8 million U I.M. + 1gm probencid
+
Doxycycline 100mg twice daily for 10 – 14 days
This regimen cover N.G, chlamydia and few anaerobes

Another regimen
Metronidazole + Tetracycline orally

(B) Inpatient regimen
Criteria for hospitalization
1- Diagnosis is uncertain (exclude appendicitis, ectopic)
2- Suspected pelvic abscess
3- Pregnancy
4- IUD
5- Temp. > 38°c
6- Adolescent
7- Nausea and vomiting
8- Failure to respond to oral antibiotics within 48hr

Regimens
1] Cefoxitin 2gm I.V. / 6hr
+ Doxycycline 100mg I.V. / 12hr
for at least 4 days or 2 days after patient is a febrile
then doxycycline 100mg orally to complete 2w
this regimen cover all pathogens

2] Clindamycin 600mg / 6hr
+
Gentamycin 2mg/kg 3 times / day followed by 1.5gm /kg 3 times / day for 4 days or 2 days after being a febrile
Then clindamycin 450mg p.o./6hr to complete 10 days
This regimen moderately cover chlamydia but no coverage for PPNG

3] Metronidazole
+ Doxycycline 100mg I.V. / 12hr
for 4 days or 2 days after being a febrile
then continue both drugs for 2 weeks orally
this regimen moderately cover gm –ve aerobes but no coverage for gm +ve aerobes or PPNG

4] Cefotaxime 1gm / 6hr
+
Metronidazole 1gm / 12hr. rectal supp.

Therapeutic failure: occur if:
1- No improvement for 48hr.
2- CT or U/S to reassess the possibility of T.O. abscess
3- Wrong diagnosis
4- Resistant pathogens
5- Pelvic thrombophelebitis

In this case, laparoscopy is indicated
If salpingitis is diagnosed (culdesac, tubal exudate cultured) ® give triple antibiotics
- Ampicllin + Gentamycin + Clindamycin
If no response, add heparin to cover the possibility of thrombophelebitis.
Pelvic Abscess

Aetiology : pelvic abscess can be divided acc. to mode of infection into:
1) Primary: due to ascending infection without predisposing factor i.e. without surgery, trauma or pregnancy
2) Secondary
a- Following pregnancy:
1- Postabortal infection
2- Purpeural infection
3- Injected chronic ectopic preg.

b- Direct extension
e.g. following appendicitis or diverticulitis

c- Following surgery
e.g. cuff abscess

The proportion of patients falling into the different etiologic groups will differ in different population will depend on certain factors
1- Abortion practice
2- Surgical technique
3- Resistance to infection

Microbiology
Any pathogenic or potentially pathogenic org. introduced into the upper genital tract can cause infection

· In primary and postpregnancy pelvic infection:
The route of entry is usually via the vagina and cx so, in such patients, the organisms isolated from the upper genital T. are the same as those which can normally be found lower genital tract
* In primary ascending infection
It is thought to be initiated by gonococcal infection of endocx and in those progressed to pelvic abscess, a mixed growth of organisms is nearly always found.
i.e. pelvic abscess in this care is polymicrobial
1- N. gonorrhea
2- Chlamydia T.
3- Anaerobes e.g. bacteroides
4- Mycoplasma hominis
5- Aerobes (gm +ve and gm –ve) e.g. E coli, enterobacter strept. gp. B., staphylococci. Klebsiella

* In postpergnancy infection: most authors stress the importance of anaerobic infection which results mainly from bacteroides species

In postsurgical injection
The organisms are those found in the lower genital tract of normal a symptomatic women

In isolated ovarian abscess: mixed flora of aerobes and anaerobes with actinomyces israeli

Pathogenesis
(A) Primary ascending infection:
It is suggested that gonococci become attached to spermatozoa to reach the f.t. following intercourse
The organism attaches to mucosal epith., penetrates it via phagocytosis ® destruction of epith. and cilia. Also, further destruction is caused by lipopolysaccharide endotoxin
This destruction ® production of purulent exudate which at early stages (when the tube is patent) exudes from the fimbrial and ® peritonitis
The area involved is walled off by bowel, omentum and surrounding structures ® pelvic abscess which is fed by purulent exudate from the f.t.
The abscess may remain localized to the tube and ovary or it may involve other structures during this stage, the ovary may be involved. It is suggested that ovulation site serves as portal of entry of organisms into the ovary ® tuboovarian abscess.
At any point of progression, rupture may occur and if the fimbrial end is blocked ® pyosalpinx.
Tuboovarian abscess is usually bilateral but unilateral tuboovarian abscess is reported especially with IUD

(B) Postsurgical infection:
Infection is initiated by direct contact of freshly traumatized tissue with pathogenic organisms
The tissue is traumatized or devitalized 2ry to crush clamp technique and due to suture ligature which represent nidus for infection.
Also, hemoglobin accumulates at the site of operation and this interfere with host defense mechanism by inhibiting leukocytes to phagocytose bacteria

The organisms found in postsurgical infection are those which can be found in the lower genital tract of normal a symptomatic women

Infection may be in the form of:
· Vaginal cuff abscess: in the area bet. vag. epith. and peritoneum following abd. or vaginal hysterectomy
or · Tuboovarian or isolated ovarian abscess (true abscess)

Isolated ovarian abscess without involvement of other pelvic organs are usually a manifestation of postsurgical infection.

(C) Primary ovarian abscess
Is an entity which is different from tuba ovarian abscess in which the wall of the abscess is composed of f.t. and ovarian parenchyma while in ovarian abscess, infection occur only in ovarian parenchyma.
Also, primary ovarian abscess is an unusual condition bacteria can gain access to ovarian parenchyma by haematogenous or lymphatic spread.
However, most primary ovarian abscess occur because bacteria present around the ovary gain access to the parenchyma through a break in the ovarian capsule either naturally by ovulation or by surgical procedure.

A primary ovarian abscess is usually unilateral but if bilateral, it indicates heamatogenous or lymphatic spread (from distant site e.g. tonsillitis).
The organism can reach the ovary from
· Fallopian tube
· Vagina during or after hysterectomy
· IUD assoc. infection
· Appendicitis, diverticulitis or any other condition causing peritonitis
A mixed flora of anaerobic and aerobic bacteria is usually present and actinomyces Israeli with sulfur granules are identified in few cases

Clinical presentation
A) Uncomplicated tuboovarian abscess
The same clinical picture of uncomplicated salpingitis differentiation require determination of an inflammatory adnexal mass

· The patient is usually in the 3rd or 4th decade
· 1/3 patients are nullipara
· 1/3 patients have history of PID or previous hospitalization for pelvic abscess
· Pelvic abscess in postmenopausal woman in usually assoc. with disease of intestinal tract such as ruptured appendix or sigmoid diverticulum

On examination
· Patient appears ill with temp. elevated
· She walks slowly with the hand on lower abdomen
· Abdominal distention and direct and rebound tenderness in the lower abdominal quadrant
· Pelvic examination is extremely tender with tender cervical mobility
· An irregular, tender, fixed inflammatory mass may be felt on one or both sides of the pelvis. the mass may be small or may extend out of the pelvis into the lower abdomen or it may dissect the rectovaginal septum and felt on rectovaginal examination

Diagnosis
1- ESR, WBCs
2- Laparoscopy: may be helpful but invasive
3- Non-invasive procedures :
- U/S, CT
- Radionuclide scanning

B) Ruptured tuboovarian abscess
· Symptoms
Acute progressive pelvic pain which is so severe that the patient can accurately identify the time and place of its occurrence identify the time and place of its occurrence

· Examination
- Patient appear ill, dehydrated
- Abdominal distention
- Absent intest. sound
- Signs of generalized peritonitis with shifting dullness
- Pelvic mass is felt in 50% of cases
- Fever, tachycardia, leucocytosis
- Culdecentesis ® purulent material

C) Postoperative pelvic abscess
[1] Vaginal cuff abscess or infected haematoma:
· Usually presents with fever and sensation of fullness or vaginal discomfort in the lower abdomen:
· Typically infected, foul smelling haematoma
it characteristically occur 48hr. postoperatively

2] True pelvic abscess
tend to present at a later date often after discharge from the hospital
It presents with fever, abdominal pain, tender palpable pelvic mass

N.B.: Characteristically, posthysterectomy adnexal mass are high in the pelvic. So, vaginal evacuation is not the optimal approach for the management of this abscess

Management of pelvic abscess
Whatever the etiological factor involved in the pathogenesis of pelvic abscess, the initial approach to the problem is the same
Once diagnosis has been made, the patient is admitted to hospital and conservative management is started. When a diagnosis of ruptured TOA is evident, early surgical intervention is indicated

ttt. consists of 3 lines
- Supportive therapy
- Antibiotic therapy
- Surgical intervention

[1] Supportive therapy
· Baseline biochemical and haematological investigations
· Rest in semifowler position
· I.V. fluids with electrolyte balance
· Analgesia

[2] Antibiotic therapy
the abscess is a unique environment characterised by:
· Low level of O2 tension which allow anaerobes to proliferate
· Circulatory compromise preventing antibiotics from reaching the area
· Poor phagocytosis by neutrophil
these factors are imp. in the resistance of these infections to antimicrobial therapy

Antibiotics given depend on sensitivities obtained the material obtained by culdecentesis or Bl. culture combination antibiotics is usually needed
· Coliforms are affected by
- aminoglycoside
- ampicillin
- cephalosporin
· Anaerobes are affected by
- metronidazole
- clindamycin
- chloramphenicol
so, combination of aminoglycoside or ampicillin + clindamycin or metronidazole
N.B. penicillin + chloramphenical were used (cheap and effective) effective against all org. except pseudomonas, but there is concern about the rare complication of aplastic anaemia
However, this complication does not occur if the dose not exceed 24gm

[3] Surgical intervention
Indications
· Ruptured TOA
· Diagnosis is in doubt
· No evidence of : response for 24hr
· Persistent generalized peritonitis for 24hr
· size does not ¯ by 48hr

Approaches
Clopotomy or laparotomy

* Colpotomy: done when 3 requirements
· Abscess in mid line or nearly so
· Abscess is cystic or fluctuant
· Abscess dissecting the rectovaginal septum or bulging in the posterior fornix
However, colpotomy will not cure all cases and about 1/3 of patients will require subsequent abdominal operation colpotomy is definitive curative procedure only in posthysterectomy abscess (cuff abscess) but in other abscesses, the chance of failure due to incomplete drainage of multilocular abscess is present

* Laparotomy
(A) unruptured pelvic abscess
the main approach for majority of patients when pelvic abscess is abdominal
· Midline subumblical incision: is made to allow exposure of the pelvis and extension to upper abdomen in case of ruptured abscess
· The operative procedure depend on the extent of pathology and etiology of the abscess
1- In postpregnancy infection
the uterus is usually involved. So, the ttt will be hysterectomy + BSO

2- In ascending infection
· More conservative surgery is needed and will depend on the site of the abscess
· Drainage of the abscess alone is not adequate and it is important to remove as much of the infected tissue to avoid recurrence of abscess
· The following alternatives may be done:
- Unilateral salpingectomy
- Unilateral salpingoophrectomy
- Bilat. salpingectomy
- Bilat. salpingoophrectomy
- Bilat. salpingectomy and unilat. oophrectomy
- Drainage only
rarely, hysterectomy is done

(B) Ruptured abscess
· Immediate laparotomy as delay for 24hr ® 80% mortality
· Identify the extent of pathology
· Ensure adequate lavage and drainage
· The affected andexal tissue is removed and hysterectomy is only performed if infection was following pregnancy with involvement of the uterus
· Intraoperative lavage with povidine iodine soln or normal saline with antibiotics
· Closed suction drainage at the pelvic cavity

MANAGEMENT OF ACUTE PELVIC INFLAMMATORY DISEASE .Green-top Guideline ,November 2008,RCOG

MANAGEMENT OF ACUTE PELVIC INFLAMMATORY DISEASE
This is the second edition of this guideline, which was previously published in 2003 under the same title.
1. Purpose and scope
Pelvic inflammatory disease (PID) is usually the result of infection ascending from the endocervix causing
endometritis, salpingitis, parametritis, oophoritis, tubo-ovarian abscess and/or pelvic peritonitis. While sexually
transmitted infections (STIs) such as Chlamydia trachomatis and Neisseria gonorrhoeae have been identified
as causative agents, additional STIs including Mycoplasma genitalium, anaerobes and other organisms may
also be implicated.PID is a common cause of morbidity and accounts for one in 60 general practitioner consultations by women
under the age of 45 years.6 Delays of only a few days in receiving appropriate treatment markedly increase
the risk of sequelae, which include infertility, ectopic pregnancy and chronic pelvic pain. Sequelae may also
have significant healthcare costs.9 This guideline applies to women requiring treatment for confirmed or
suspected acute PID being treated in an outpatient or inpatient setting by primary and secondary care
practitioners.
There are marked variations in the antimicrobial regimens used in the treatment of PID, reflecting uncertainty
in the optimal treatment schedule.10 The guideline contains recommendations for treatment and graded
evidence to support their use.
2. Identification and assessment of evidence
A Medline search was performed covering 1963 to August 2007 looking for the following terms in the title or
abstract: ‘pelvic inflammatory disease’, ‘adnexitis’, ‘oophoritis’, ‘parametritis’, ‘salpingitis’ or ‘adnexal disease’
(the dataset for 1963–86 was limited to Argonne Information Management journals and human subjects); citations were identified. A search of the Cochrane database revealed no directly relevant systematic reviews.
A search of the Cochrane controlled trials register using a search strategy of ‘pelvic inflammatory disease’,
‘adnexitis’, ‘oophoritis’, ‘parametritis’, ‘salpingitis’ or ‘adnexal disease’ identified 356 citations. The following
guidelines and reports were also reviewed: 2006 US Centers for Disease Control STD treatment guidelines,Royal College of Obstetrics and Gynaecology Study Group proceedings on PID 1996,1 2004 Health
Technology Assessment report, The Clinical Effectiveness and Cost Effectiveness of Antibiotic Regimens for Pelvic Inflammatory Disease, 2005 UK National Guidelines on Sexually Transmitted Diseases and 2007
European guidelines for the management of pelvic inflammatory disease.
The recommendations given in this guideline have been graded according to the guidance for the development of RCOG Green-top Guidelines.

3.Making a diagnosis of acute PID
3.1 Clinical
A low threshold for empiric treatment of PID is recommended because of the lack of definitive clinical
diagnostic criteria and because the potential consequences of not treating of PID are significant. In clinically severe cases, referral to hospital for treatment and further investigation is advisable.
The following clinical features are suggestive of a diagnosis of PID:
● bilateral lower abdominal tenderness (sometimes radiating to the legs)
● abnormal vaginal or cervical discharge
● fever (greater than 38°C)
● abnormal vaginal bleeding (intermenstrual, postcoital or ‘breakthrough’)
● deep dyspareunia
● cervical motion tenderness on bimanual vaginal examination
● adnexal tenderness on bimanual vaginal examination (with or without a palpable mass).
Clinical symptoms and signs lack sensitivity and specificity (the positive predictive value of a
clinical diagnosis is 65–90% compared with laparoscopic diagnosis but laparoscopy may also lack
sensitivity). The presence of excess leucocytes on a wet-mount vaginal smear is associated with
PID but is also found in women with isolated lower genital tract infection.
Laparoscopy enables specimens to be taken from the fallopian tubes and the pouch of Douglas and
can provide information on the severity of the condition. Although it has been considered the
gold standard in many studies of treatment regimens, 15–30% of suspected cases may have no
laparoscopic evidence of acute infection, despite organisms being identified from the fallopian
tubes. When there is diagnostic doubt laparoscopy may, however, be useful to exclude alternative pathologies.
Transvaginal ultrasound scanning may be helpful when there is diagnostic difficulty. When
supported by power Doppler, it can identify inflamed and dilated tubes and tubo-ovarian masses.
It may differentiate PID from acute appendicitis in a minority of cases but there is insufficient
evidence to support its routine use. Computed tomography24 and magnetic resonance
imaging25–27 can assist in making a diagnosis but the evidence is limited. A peripheral blood leucocytosis,
elevated erythrocyte sedimentation rate or C-reactive protein also support the diagnosis
and can provide a useful measure of disease severity but these are non-specific findings. There is insufficient evidence to support endometrial biopsy as a routine diagnostic test at present.
The differential diagnosis of lower abdominal pain in a young woman includes:
● ectopic pregnancy
● acute appendicitis
● endometriosis
● irritable bowel syndrome (and, less commonly, other gastrointestinal disorders)
● complications of an ovarian cyst, such as rupture or torsion
● urinary tract infection
● functional pain (pain of unknown physical origin).

Microbiological
Women with suspected PID should be tested for gonorrhoea and chlamydia.
Although not a prerequisite to justify initial treatment decisions, testing for gonorrhoea and
chlamydia in the lower genital tract is recommended. A positive result gives support to the clinical
diagnosis of PID and reinforces the need to treat sexual partners. The absence of confirmed
infection in the lower genital tract site does not exclude PID.
Testing for gonorrhoea should be with an endocervical specimen and tested via culture (direct inoculation on to a culture plate or transport of swab to laboratory within 24 hours) or using a nucleic acid amplification test (NAAT). If gonorrhoea is detected using a NAAT, an additional
endocervical swab should be taken for gonococcal culture to allow the reporting of antibiotic
sensitivities and revision of therapy if required (women at high risk of gonorrhoea should have an
endocervical swab for gonococcal culture taken at their first examination; for example, where the
woman’s partner has gonorrhoea, clinically severe disease, sexual contact abroad).
Testing for chlamydia should also be from the endocervix, preferably using a NAAT (such as polymerase chain reaction, strand displacement amplification).
Taking an additional sample from the urethra can increase the diagnostic yield for gonorrhoea and
chlamydia but is only recommended if the more sensitive NAAT is not available. A first catch urine
or self-taken vulvovaginal swab sample provides an alternative sample for some NAATs.
The absence of endocervical or vaginal pus cells on a wet-mount smear has a good negative
predictive value (95%) for a diagnosis of PID but their presence is non-specific (poor positive
predictive value (17%).
Other organisms, including M. genitalium have been associated with PID but routine screening
is not yet justified because of limited information on prevalence, natural history, treatment and cost
effectiveness.
Further advice on the appropriate testing for STIs is available from the National Screening and
Testing Guidelines for Sexually Transmitted Infections (www.bashh.org/guidelines).
4. Starting treatment
4.1 How should PID be managed in the outpatient setting?
Information on current and recent medication should be obtained.
Interactions between antibiotic therapy and hormonal contraception and other patient medications
should be assessed and appropriate action taken.
Outpatient antibiotic treatment should be commenced as soon as the diagnosis is suspected.
In mild or moderate PID (in the absence of a tubo-ovarian abscess) there is no difference in
outcome when women are treated as outpatients or admitted to hospital. It is likely that delaying treatment, especially in chlamydia infections, increases the severity of the condition and the risk of long-term sequelae such as ectopic pregnancy, subfertility and pelvic pain.

Outpatient antibiotic treatment should be based on one of the following regimens:
● oral ofloxacin 400 mg twice daily plus oral metronidazole 400 mg twice daily for 14 days
● intramuscular ceftriaxone 250 mg single dose,* followed by oral doxycycline 100 mg twice daily plus metronidazole 400 mg twice daily for 14 days.* Cefoxitin has a better evidence base for the treatment of PID than ceftriaxone but is not easily available in the
UK. Ceftriaxone is therefore recommended.
Broad-spectrum antibiotic therapy is generally required to cover N. gonorrhoeae, C. trachomatis and
anaerobic infection. Ofloxacin should be avoided in women who are at high risk of gonococcal
PID because of increasing quinolone resistance in the UK. Those women at high risk of acquiring
gonorrhoea include those whose partner has gonorrhoea, in clinically severe disease or if there is
a history of sexual contact abroad.
Metronidazole may be discontinued in those women with mild or moderate PID who are unable
to tolerate it, since its addition provides uncertain additional efficacy in this patient group.
Clinical trial evidence for the following regimen is less strong but it may be used as an alternative
to the treatments above:
● intramuscular ceftriaxone 250 mg immediately, followed by azithromycin 1 g/week for 2 weeks.
Although the combination of oral doxycycline and metronidazole (without ceftriaxone) has been
used to treat PID in the UK, there are no clinical trials adequately assessing its effectiveness and its
use in isolation is not recommended. Data supporting azithromycin monotherapy for PID is
also limited at present and its use without the addition of ceftriaxone is not recommended.
There are currently no randomised controlled trial data to support the use of an oral (rather than parenteral) cephalosporin as part of the treatment regimen. Tissue levels of the antibiotic are likely
to be lower following oral administration.
A detailed explanation of their condition should be provided to women, with particular emphasis on the
long-term implications for their health and the health of their partner(s). This should be reinforced with
clear and accurate written information.
When giving information to patients, the clinician should consider the following:
● an explanation of what treatment is being given and its possible adverse effects
● that following treatment fertility is usually maintained but there remains a risk of future infertility, chronic pelvic
pain or ectopic pregnancy
● repeat episodes of PID are associated with an exponential increase in the risk of infertility
● future use of barrier contraception will significantly reduce the risk of PID
● the need to screen her sexual contacts for infection to prevent her becoming reinfected
● clinically more severe disease is associated with a greater risk of sequelae
● the earlier treatment is given the lower the risk of future fertility problems.
A suitable patient information leaflet for PID is available at: www.rcog.org.uk/resources/public/pdf/Acute_
PID_2004.pdf.
4.2 What hospital treatment should be given and when should it be recommended?
Admission to hospital would be appropriate in the following circumstances:

surgical emergency cannot be excluded
● clinically severe disease
● tubo-ovarian abscess
● PID in pregnancy
● lack of response to oral therapy
● intolerance to oral therapy.
Inpatient antibiotic treatment should be based on intravenous therapy which should be continued until
24 hours after clinical improvement and followed by oral therapy.
Recommended regimens are:
● ceftriaxone 2 g by intravenous infusion daily plus intravenous doxycycline 100 mg twice daily,* followed by oral doxycycline 100 mg twice daily plus oral metronidazole 400 mg twice daily for a total of 14 days
* Oral doxycycline may be used if tolerated.
● intravenous clindamycin 900 mg three times daily plus intravenous gentamicin,* followed by either
● oral clindamycin 450 mg four times daily to complete 14 days
OR
● oral doxycycline 100 mg twice daily plus oral metronidazole 400 mg twice daily to complete 14 days.
* Gentamicin should be given as a 2 mg/kg loading dose followed by 1.5 mg/kg three times daily [or a single daily dose of 7 mg/kg may be substituted].
● intravenous ofloxacin 400 mg twice daily plus intravenous metronidazole 500 mg three times daily for 14 days.
The clinical trial data support the use of cefoxitin for the treatment of PID but this agent is not easily available
in the UK so ceftriaxone, which has a similar spectrum of activity, is recommended. An alternative thirdgeneration
cephalosporin would also be acceptable.
Intravenous doxycycline is available from IDIS World Medicines (+44 [0] 1932 824000). If parenteral
gentamicin is used then serum drug levels and renal function should be monitored.
The choice of an appropriate treatment regimen will be influenced by robust evidence on local antimicrobial
sensitivity patterns, robust evidence on the local epidemiology of specific infections, cost, the woman’s
preference and compliance and severity of disease.
Evidence of the efficacy of antibiotic therapy in preventing the long-term complications of PID is currently
limited.
4.3 Treatment in pregnancy and in young women
A pregnancy test should be performed in all women suspected of having PID to help exclude an ectopic
pregnancy. When the risk of ectopic pregnancy is judged clinically to be high, the pregnancy test should be
repeated 21 days after the date of last unprotected intercourse.
The risk of giving any of the recommended antibiotic regimens in very early pregnancy (before a positive
pregnancy test) is low, since significant drug toxicity results in failed implantation (UK National Teratology
Information Service).
PID is rare in women with an intrauterine pregnancy except in the case of septic abortion. In septic abortion,
the infective organism is unlikely to be a sexually transmitted pathogen. Cervicitis may, however, occur in a
pregnancy and is associated with increased maternal and fetal morbidity. Treatment regimens will be dependent
upon the organisms isolated. Drugs known to be toxic in pregnancy, such as tetracyclines, should be avoided.

A combination of cefotaxime, azithromycin and metronidazole for 14 days may be used. The risks associated
with metronidazole are uncertain but no confirmed associations with adverse outcomes have been reported.
Ofloxacin should be avoided, where possible, in young women, when bone development is still occurring.
However, this recommendation is based on data from animal studies and no problems have been reported in
human subjects, so the British National Formulary currently recommends that ofloxacin may be used in
children where other options are limited. Doxycycline can be safely used in children over the age of 12 years.
A particularly low threshold for diagnosing and treating PID in women under the age of 25 years is
appropriate, owing to the higher incidence of disease in this group and the potential impact on future fertility.
4.4 Treatment in a woman with an intrauterine contraceptive device
Consideration should be given to removing an intrauterine contraceptive device (IUD) in women
presenting with PID, especially if symptoms have not resolved within 72 hours.
The randomised controlled trial evidence for whether an IUD should be left in place or removed
in women presenting with PID is limited. Removal of the IUD should be considered and may be
associated with better short-term clinical outcomes but the decision to remove it needs to be
balanced against the risk of pregnancy in those who have had otherwise unprotected intercourse
in the preceding 7 days. Hormonal emergency contraception may be appropriate for some women
in this situation.
5. Other modes of treatment
Surgical treatment should be considered in severe cases or where there is clear evidence of a pelvic
abscess.
Consider drainage of an abscess and in noting its position, the possibility that the abscess may have
arisen from the appendix or colon.
Laparoscopy may help early resolution of the disease by division of adhesions and drainage of
pelvic abscesses. Ultrasound-guided aspiration of pelvic fluid collections is less invasive and may
be equally effective.
6. Management of sexual partner(s) of women with PID
When a sexually transmitted infection is either proven or likely to be the cause of PID, the current sexual
partner(s) should be contacted and offered health advice and screening for gonorrhoea and chlamydia.
Other recent sexual partners may also be offered screening. Tracing of sexual partners within a 6-month period of the onset of symptoms is recommended but this time period may be influenced
by the sexual history. The risk of detecting STIs in the partners of women with PID is high.Women should be advised to avoid intercourse until they and their partner have completed the treatment
course. Gonorrhoea diagnosed in their sexual partner should be treated appropriately and
concurrently with the index woman. Concurrent empirical treatment for chlamydia is
recommended for all sexual partners, owing to the variable sensitivity of currently available
diagnostic tests. If adequate screening for gonorrhoea and chlamydia in the sexual partner(s) is not
possible, empirical therapy for both gonorrhoea and chlamydia should be given.Currently recommended regimens are available at www.bashh.org. Tracing of sexual partners is not required
where a non-sexually transmitted pathogen has been clearly identified as the cause of infection.

Referral of the index woman and her partner to a genitourinary medicine/sexual health clinic is
recommended to facilitate contact tracing and infection screening.
7. Review of women with PID
In the outpatient setting, review at 72 hours is recommended, particularly for those with a moderate or
severe clinical presentation.
Failure to improve clinically suggests the need for further investigation, to exclude competing diagnoses, and
may require admission for parenteral therapy and/or surgical intervention.
Further review 4–6 weeks after therapy may be useful to ensure:
● adequate clinical response to treatment
● compliance with oral antibiotics
● screening and treatment of sexual contacts
● awareness of the significance of PID and its sequelae
● that a repeat pregnancy test is negative, if clinically indicated.
Repeat testing for gonorrhoea after treatment is recommended in those initially found to be
infected unless sensitivity testing of the isolate confirms sensitivity to the prescribed antibiotic.
Repeat testing for chlamydia and gonorrhoea is appropriate in those in whom persisting
symptoms, compliance with antibiotics and/or tracing of sexual contacts indicate the possibility of
persisting or recurrent infection.
A repeat chlamydia and gonorrhoea test is not otherwise required.
8. Women who are infected with HIV
Women with PID who are also infected with HIV should be treated with the same antibiotic regimens as
women who are HIV negative.
Women who are infected with HIV may have clinically more severe PID but respond equally well
to treatment as women who are not infected. Standard antibiotic treatment as outlined above is
therefore appropriate and hospital admission is only required for those with clinically severe
disease. Potential interactions between antibiotics and antiretroviral medication need to be
considered on an individual basis (information on drug interactions with antiretroviral drugs is
available at www.hiv-druginteractions.org).
Women with HIV should be managed in conjunction with their HIV physician.
9. Contraception options and PID
Women on hormonal contraception presenting with breakthrough bleeding should be screened for
genital tract infection, especially C. trachomatis.
The use of the combined oral contraceptive pill has usually been regarded as protective against symptomatic
PID. Retrospective case–control and prospective studies have, however, shown an association with an
increased incidence of asymptomatic cervical infection with C. trachomatis.61 This has led to the suggestion
that the oral contraception may mask endometritis.62

An IUD only increases the risk of developing PID in the first few weeks after insertion. One European
randomised trial compared efficacy and continuation rates of copper-containing IUDs and the levonorgestrelreleasing
intrauterine system (LNG-IUS). At 3 years, there were significantly fewer removals for PID in the
LNG-IUS group.
All women diagnosed with PID should be provided with information about future contraceptive options and
should be assisted in making an informed choice.
If a woman is likely to be at risk of future PID and requests an IUD for contraception, the LNG-IUS would
be the most appropriate choice
10. Auditable standards
Little is known about the long-term outcomes, in relation to future fertility, ectopic pregnancy and chronic
pelvic pain, following the treatment of PID. Appropriate short-term audit outcomes include:
1. Proportion of women receiving treatment with a recommended regimen – target 95%.
2. Proportion of women referred for tracing of sexual contacts – target 95%.
3. Proportion of named male contacts in STI associated PID confirmed to have been screened for infection and/or
treated – target 60%.
4. Proportion of women having an adequate sexual history documented – target 95%.
5. Proportion of women in whom microbiological investigations have been taken – target 90%.
For service organisation, please see: Royal College of Obstetricians and Gynaecologists. Standards in
Gynaecology. Report of a Working Party. 2008 [www.rcog.org.uk/resources/public/pdf/GYNStandardsWPR
(web)0608.pdf].

Antiphospholipid Syndrome and Pregnancy

Introduction :
Recognized for its associated thrombosis in the 1950s, antiphospholipid syndrome (APS) and lupus anticoagulant (LAC) are associated with pregnancy complications that include fetal loss, fetal growth restriction, preeclampsia, thrombosis, and autoimmune thrombocytopenia. It is characterized by an autoimmune process that is separate in many women from systemic lupus erythematosus (SLE) and other connective tissue diseases. Diagnosis requires clinical and laboratory findings with the clinical criteria being the primary method of diagnosis. Women with the clinical features should be tested for LAC and anticardiolipin (aCL) antibodies; most patients with APS have both LAC and aCL immunoglobulin G (IgG) antibodies.APS is classified as primary or secondary depending on its association with other autoimmune disorders. Primary antiphospholipid syndrome is diagnosed in patients demonstrating the clinical and laboratory criteria without other recognized autoimmune disease. Secondary antiphospholipid syndrome is diagnosed in patients with other autoimmune disorders such as SLE.
Antiphospholipid (aPL) antibodies belong to the large family of antibodies that react with negatively charged phospholipids (PLs) including cardiolipin, phosphatidylglycerol, phosphatidylinositol, phosphatidylserine, phosphatidylcholine, and phosphatidic acid.LAC and aCL predispose to clotting in vivo, predominantly by interfering with the antithrombotic role of PLs; thus, it is associated with clinical thrombosis, not bleeding. The aPL autoantibodies bind moieties on negatively charged PLs or moieties formed by the interaction of negatively charged PLs with other lipids, PLs, or proteins.

Pathophysiology :

The biologic effects mediated by the human aPL antibodies include
(1) reactivity with endothelial structures, which disturbs the balance of prostaglandin E2/thromboxane production;
(2) interaction with platelet PLs, with consequent up-regulation of platelet aggregation;
(3) dysregulation of complement activation; and
(4) interaction of aPL with phosphatidylserine exposed during trophoblast syncytium formation, which raises the possibility of a more direct effect of these autoantibodies on placental structures.
In patients with primary APS, the presence of the 3 aCL isotypes plus LAC has been associated with a higher number of recurrent spontaneous abortions compared with other possible combinations of aCL isotypes.
The association between aPL antibodies and particular human leukocyte antigen (HLA) alleles and HLA-linked epitopes has been reported in studies of patients with lupus erythematous (eg, HLA-DR7, HLA-DR4). The HLA-DR3 phenotypes seem to predispose to the formation of aCL antibodies and antinuclear antibodies (ANAs), but this has not been confirmed in patients. However, particular HLA alleles associated with recurrent miscarriage have not been reported.
Animals immunized with aCL or with the cofactor beta-2 glycoprotein I (b2GPI) develop clinical manifestations of APS, including fetal loss, thrombocytopenia, and neurologic and behavioral dysfunction, along with elevated levels of aPL antibodies.
aCL antibodies bind to b2GPI, or a complex formed by this b2GPI is a platelet adhesin glycoprotein and cardiolipin. Exposure of endothelial cells to anti-b2GPI antibodies and their corresponding peptides leads to the inhibition of endothelial cell activation, as shown by decreased expression of adhesion molecules E-selectin, intercellular adhesion molecule, and vascular cell adhesion molecule and of monocyte adhesion.
In vivo infusion of each of the anti-b2GPI antibodies into BALB/c mice followed by administration of the corresponding specific peptides prevents the peptide-treated mice from developing experimental APS. These fascinating results suggest that the use of synthetic peptides that focus on neutralization of pathogenic anti-b2GPI antibodies represents a possible new therapeutic approach to APS.
Passive transfer into naive mice of inherently heterogeneous aPL antibody populations, either affinity-purified or as part of whole immunoglobulin fractions, from humans with APS or autoimmune mice has been shown to induce growth retardation and fetal loss.

Frequency :
United States
Women have been reported to account for approximately 80% of patients with APS.The aPL antibodies account for 65-70% of cases of venous thrombosis in women with venous thrombosis in unusual sites (eg, cerebral portal, splenic, subclavian and mesenteric veins). The aPL antibodies are detected in approximately 2% of patients with nontraumatic venous thrombosis. Approximately 22% of women with APS have had venous thrombosis and 6.9% have had a cerebrovascular incident (over a median follow-up period of 60 mo); 24% of thrombotic events occurred during pregnancy or the postpartum period. The rate for thrombosis or stroke is 5-12%. These observations suggest that women with documented APS should not take estrogen-progestin combination oral contraceptives.SLE occurs in approximately 120 cases per 100,000 population and causes pregnancy complications in approximately 45 cases per 100,000 pregnant population.
Mortality/Morbidity
APS is one of the major causes of thrombosis and its complications in women. Arterial and venous thrombosis are both reported. Coronary artery occlusions are reported in patients with APS. Previous thrombosis in the face of the diagnosis of APS has been documented to have a rate of recurrence of 25% per year if untreated.
Maternal morbidity
Thrombosis, especially in patients with APS and a history of thrombosis is a major concern. Morbidity may also be associated with anticoagulation in patients treated with heparin or low molecular weight heparins in pregnancy. Women with APS have an increased incidence of preeclampsia, which is frequently prior to 34 weeks’, and severe preeclampsia requiring premature delivery. APS is also associated with infertility and pregnancy complications such as spontaneous abortions, prematurity, and stillbirths.
Maternal mortality
Mortality rates during pregnancy are not well characterized. Multiorgan failure has been described during pregnancy by Asherson[1 ]and during postpartum by Kochenour
Perinatal Morbidity
aPL antibodies are found in 10-15% of women at high risk for fetal growth restriction. Neonatal morbidity and mortality may be influenced by indicated preterm delivery for maternal severe preeclampsia or fetal growth restriction.Neonatal lupus dermatitis, a variety of systemic and hematologic abnormalities, and isolated congenital heart block have been
associated with APS and SLE.
Perinatal Mortality
Fetal deaths at or beyond 20 weeks' gestation may be attributed to APS involvement. The rate of fetal loss may exceed 90% in untreated patients who have APS. Therapy (including aspirin and heparin) can reduce the rate of fetal loss to 25%, as described by Cowchock et al.[3 ]
Sex
Most cases of APS (80%) are in women.
Age
APS is predominantly diagnosed in reproductive-aged women (ie, 15-55 y). This is similar to other autoimmune states.

Diagnosis :
History
The “International consensus statement for the diagnosis of antiphospholipid syndrome” was published in 1999 by Wilson et al.This serves as a set of criteria similar to the criteria for the diagnosis of other autoimmune disorders.
Diagnosis of antiphospholipid syndrome (APS) requires at least 1 clinical and 1 laboratory criterion.
Clinical criteria :
Vascular thrombosis: One or more clinical episodes of arterial, venous, or small-vessel thrombosis, occurring within any tissue or organ
Complications of pregnancy
-One or more unexplained deaths of morphologically normal fetuses at or after 10 weeks’ gestation
-One or more premature births of morphologically normal fetuses at or before 34 weeks’ gestation
-Three or more unexplained consecutive spontaneous abortions before 10 weeks’ gestation
Laboratory criteria
Anticardiolipin antibodies
- Anticardiolipin IgG or IgM antibodies present at moderate or high levels in the blood on 2 or more occasions at least 6 weeks apart
Lupus anticoagulant
- Lupus anticoagulant antibodies detected in the blood on 2 or more occasions at least 6 weeks apart, according to the guidelines of the International Society on Thrombosis and Hemostasis
Physical
APS is primarily a diagnosis based on clinical history and laboratory data. Some physical findings may be associated with primary APS, but patients with secondary APS are more likely to have findings on physical examination.
-Thrombosis or stroke - Possible residual neurologic findings
-Cutaneous manifestations
.These may include digital cyanosis, livedo reticularis, digital gangrene, and leg ulcers. The cause of these features remains otherwise unexplained.
.Other features related to cutaneous manifestations, with a cause that remains unexplained, include transient ischemic attacks or amaurosis fugax, positive result from the Coombs test, hemolytic anemia, chorea, and chorea gravidarum.
.Discoid rash (ie, erythematous raised patch with keratotic scaling and follicular plugging) is a criterion. Older lesions may be atrophic. Again, the cause remains unexplained.
.Photosensitivity with an unexplained cause is another criterion.
The following are physical findings that should be considered secondary to other autoimmune disorders and an appropriate evaluation should be undertaken.
-Arthritis: Patients may have nonerosive arthritis involving 2 or more peripheral joints, and the cause cannot otherwise be determined.
-Serositis: This may be (1) pleuritis or pleural effusion or (2) pericarditis or pericardial effusion, the cause of which cannot be explained.
-Renal disorder: Proteinuria of 0.5 g/d or the presence of cellular casts, without another cause, is a criterion for APS.
-Neurologic disorder: Criteria include seizures in the absence of other causes or psychosis in the absence of other causes.
-Hematologic disorder: Features, without an otherwise explainable cause, include
(1) hemolytic anemia with reticulocytosis,
(2) leukopenia of less than 4000 cells/mm3 on at least 2 occasions,
(3) lymphopenia of less than 1500 cells/mm3, or
(4) thrombocytopenia of less than 100,000 cells/mm3.
-Immunologic disorder: Again, the cause remains unexplained.
The clinical manifestations of SLE include the following:
.Skin lesions - 84-71%
.Arthritis - 63-95%
.Nephritis - 46-77%
.Raynaud phenomenon - 10-58%
.Neuropsychiatric features - 0-59%
.Lymphadenopathy - 0-58%
.Pleurisy - 37-56%
.Mucous membrane ulceration - 7-54%
.Pericarditis - 29-45%
.Splenomegaly - 9-18%
.Aseptic necrosis - 0-10%
.Clinical evidence of glomerulonephritis is found in more than 50% of cases. However, if biopsies are performed on all patients, the incidence of some nephritis may be as high as 90%. SLE is associated with encephalopathy and seizures, to a lesser degree with ischemic stroke, and, rarely, with subarachnoid hemorrhage.

Causes :
Like other autoimmune disorders, APS does not have a known etiology.Passive transfer of maternal antibodies mediate autoimmune disorders in the fetus and newborn. The mechanism of excess autoantibody production and immune complex formation is not well understood, although current investigation is focused on abnormal regulator functions and the possibility of a slow virus infection. In addition, certain genetic factors may be important, as indicated by a number of family and twin studies for systemic lupus erythematosus (SLE) and the demonstration of an increased frequency of HLA-DR2, HLA-DR3, and HLA-DR4 null alleles in patients with SLE.
Significant controversy still exists regarding the role of oral contraceptives in inducing SLE. Antinuclear antibodies (ANAs) associated with LP were reverted to negative when the drug was discontinued. Some patients using the intrauterine device complain of dysmenorrhea and recurrent infections, especially those taking prednisone and cytotoxic drugs. Although the incidence of SLE in families was initially believed to be no greater than in the general population, this is no longer thought to be true.
PL molecules are ubiquitous in nature and are present in the inner surface of the cell (ie, on the inner or outer surface of the cell membrane or intracellular organelles) and in microorganisms. Therefore, during infectious disease processes, including viral (eg, HIV, Epstein-Barr virus [EBV], cytomegalovirus [CMV], adenoviruses), bacterial (eg, bacterial endocarditis, tuberculosis, Mycoplasma pneumonia), spirochetal (eg, syphilis, leptospirosis, Lyme disease), and parasitic (eg, malaria infection), the disruption of cellular membranes may occur during cell damage. PLs release and stimulate aPL antibodies.
The SWISS PROT protein database revealed high homology between the hexapeptides that bind to ILA-1, ILA-3, and H-3 mAbs and the membrane particles of different bacteria and viruses. The sequence LKTPRV showed homology to 8 different bacteria (eg, Pseudomonas aeruginosa) and homologies to 5 types of viruses (ie, polyoma virus, human CMV, adenovirus). The sequence TL-RVYK shows homology to 8 different bacteria, including Haemophilus influenzae, Neisseria gonorrhoeae, and Shigella dysenteriae, and to viruses such as EBV and HIV. Therefore, data might support the theory predicting that epitope mimicry is involved in the propagation of the autoimmune status.
Autoantibodies include the following:
Antiphospholipid
Anticardiolipin
Antiphosphatidylinositol
Antiphosphatidylserine
Antiphosphatidylcholine
Anti–beta-2 glycoprotein I
Antinuclear antibody
Anti-DNA (double- or single-stranded)
Anti-Sjögren syndrome A antibody (Ro)
Anti-Sjögren syndrome B antibody (Ia)
Antibodies against microorganism(s) associated with infection or vaccination include the following:
Antibacterial PL
Antibacterial protein
Antiviral glycoprotein
Anti-Sjögren syndrome A antibody (Ro) and anti-Sjögren syndrome B antibody (Ia): These are associated with neonatal lupus erythematosus, including congenital complete heart block. These antibodies are usually present in patients with Sjögren syndrome.

Differential Diagnoses :
Preeclampsia
Thymic Tumors

Other Problems to Be Considered :
In women meeting the clinical criteria of early pregnancy loss, care must be taken to assure that the evaluation of spontaneous abortions prior to the 10 weeks’ gestation has included the appropriate evaluation to be considered unexplained.
Other causes of thrombocytopenia such as HIV infection, drug-induced thrombocytopenia, thrombotic thrombocytopenia, gestational thrombocytopenia, and preeclampsia should be considered. Other autoimmune disease should be ruled out in patients with thrombocytopenia.
Many manifestations of SLE can be seen in women with APS. A complete evaluation to exclude SLE as a primary disorder is appropriate if symptoms are present.

Laboratory Studies :

.Antiphospholipid syndrome (APS) is diagnosed when the patient has lupus anticoagulant (LAC) or IgG or IgM anticardiolipin (aCL) in medium-to-high levels, or both, on 2 occasions at least several weeks apart.
-Antiphospholipid (aPL) antibodies are detected by conventional and specific solid-phase or enzyme-linked immunoassays. Results are measured as GPL (IgG aCL), MPL (IgM aCL), or aPL (IgA aCL) units and reported in semiquantitative terms such as negative, low-positive, medium-positive, or high-positive.
-Isolated IgA aCL results are also of uncertain clinical significance and are not diagnostic of APS. An easy and reliable test would significantly help detection and follow-up of affected patients.
-Autoantibodies include antinuclear antibodies (ANAs), aCL antibodies, anti-DNA antibodies (single- or double-stranded), and anti-b2GPI.
.SLE is associated with lower serum complement levels measured either as total hemolytic complement activity CH50 or as levels of the third and fourth components of complement C3 and C4, respectively. Decreased levels of these are indicative of consumption by immune complexes. However, preeclampsia is associated with an increased serum complement level.
.Indications for testing for aPL antibodies include the following:
Obstetric indications
Unexplained fetal death or stillbirth
Recurrent pregnancy loss (3 or more spontaneous abortions with no more than 1 live birth)
Unexplained second or third trimester fetal death
Severe preeclampsia at less than 34 weeks’ gestation
Unexplained severe fetal growth restriction
Chorea gravidarum
Nonobstetric indications
Nontraumatic thrombosis or thromboembolism (venous or arterial)
Stroke, especially in individuals aged 24-50 years
Unexplained transient ischemic attack
Unexplained amaurosis fugax
Autoimmune thrombocytopenia
Autoimmune hemolytic anemia
Unexplained prolongation of a clotting assay
Transient ischemic attacks
Livedo reticularis
SLE or other connective tissue disorder
False-positive serologic test result for syphilis
.Laboratory criteria for the diagnosis of APS are as follows:
.LAC is detected by PL-dependent clotting assays, without correction with normal plasma. Results are confirmed by demonstrating PL dependency. The activated partial thromboplastin time (aPTT) is prolonged. Sera are screened for anticoagulant activity by mixing them with platelet-pool normal sera and assaying the aPTT. Several laboratory measurements are available for the assessment of LAC.
.For aCL or anti-b2GPI antibodies, an IgG isotype greater than 12-20 GPL units (medium- to high-positive) detected in a standardized assay using standard serum calibrators is indicative.
Hematologic and serologic values of APS are as follows:
Lupus anticoagulant
Prolonged clotting times with any of the following:
aPTT
Kaolin clotting time
Dilute Russell viper venom time
Plasma clotting time
These prolongations should be confirmed with one of the following:
Mixing studies with normal plasma, clotting time will remain prolonged with LA
Platelet neutralization test (recommended by some authorities
Anticardiolipin antibodies: Many aCL antibodies correlate poorly with the clinical manifestations of APS. At present, only IgG and IgM in moderate and high levels are recommended to be used in the diagnosis of APS.
False-positive results from the VDRL test may be present.
All studies need to be repeated in at least 6 weeks for confirmation before the diagnosis of APS is appropriate.

Imaging Studies :
Appropriate neurologic or imaging studies should be performed based on clinical findings (ie, in the presence of CNS symptoms, a CT scan or MRI).
Histologic Findings :
Histologically, 6 classes of lupus glomerulonephritis have been recognized by the World Health Organization.
Class I - Normal glomeruli observed with light microscopy; may show deposits with immunofluorescence or electron microscopy
Class II - Mesangial lesions
Class III - Focal proliferative glomerulonephritis
Class IV - Diffuse proliferative glomerulonephritis
Class V - Membranous glomerulonephritis
Class VI - Diffuse glomerular sclerosis

Treatment :

Medical Care
Pregnant women with antiphospholipid antibody syndrome (APS) are considered high-risk obstetric patients, and medical care is instituted with this in mind.
Obstetric care
Patients should be counseled in all cases regarding symptoms of thrombosis and thromboembolism and should be educated regarding, and examined frequently for, the signs or symptoms of thrombosis or thromboembolism, severe preeclampsia, or decreased fetal movement.
In patients with poor obstetric histories, evidence of preeclampsia, or evidence of fetal growth restriction, ultrasonography is recommended every 3-4 weeks starting at 18-20 weeks’ gestation.
Human chorionic gonadotropin (hCG) values in the first trimester can be followed to evaluate the viability of the pregnancy. If hCG levels are increasing normally (ie, doubling every 2 d) in the first month of pregnancy, a successful outcome is predicted in 80-90% of cases. However, when the increases are abnormal (ie, slower), a poor outcome is predicted in 70-80% of cases. Initiation of heparin in the face of a failing pregnancy should be undertaken with caution due to bleeding risks.
In patients with uncomplicated APS, ultrasonography is recommended at 30-32 weeks’ gestation to assess fetal growth. Lagging fetal growth may reflect uteroplacental insufficiency in patients with APS.
Anticoagulation with heparin is recommended in APS and pregnancy. Low molecular weight heparin (LMWH) may be used in these patients.
Importantly, counsel the patient regarding potential adverse effects of heparin. Heparin-induced osteoporosis occurs in 1-2% of cases.
Drugs such as chloroquine and cytotoxic agents are not recommended during pregnancy, and patients should stop taking these drugs several months prior to becoming pregnant.
Warfarin may be substituted for heparin during the postpartum period to limit further risk of heparin-induced osteoporosis and bone fracture.
Splenectomy during the early second trimester or at the time of cesarean delivery may be considered in patients with thrombocytopenia refractory to glucocorticoid therapy.
Bone density studies should be considered in patients receiving anticoagulation with heparin or LMWH due to the risks of osteopenia. This may be most important in women who have been treated in a previous pregnancy or are planning pregnancy.
Intravenous immunoglobulin (IVIG): Infused immunoglobulins may modulate aCL antibodies levels by 3 mechanisms.
Antiidiotypic antibodies may be present in the IVIG preparation. These antiidiotypic antibodies may bind autoantibodies to form idiotype-antiidiotype dimers, resulting in neutralization of autoantibody effects.
Antiidiotype antibodies may bind and down-regulate B-cell receptors, resulting in a decrease in autoantibody production.
Antiidiotype antibodies might bind receptors of regulatory T cells, resulting in suppression of lymphokine production and decreased activation of autoantibody-producing B cells.
Landry-Guillain-Barré-Strohl syndrome (LGBSS) of acute inflammatory demyelinating polyradiculoneuropathy can be seen in patients with APS and lupus.
Patients usually present with progressive bilateral and symmetrical muscle weakness accompanied by mild sensory symptoms, including paresthesia, numbness, and tingling. The disease can progress to involve the respiratory muscles, resulting in respiratory failure. Two thirds of the patients have a history of viral-like infections 1-3 weeks prior to the onset of symptoms.
Recently, CMV infection has been incriminated as a potential etiologic agent in some pregnant patients presenting with LGBSS.
Acute inflammatory demyelinating polyradiculoneuropathy is a rare disease with an incidence of approximately 1-1.5 cases per 100,000 LGBSS cases per year. LGBSS is exceedingly rare in pregnancy.
Nonobstetric care
Immunosuppressive agents are recommended for patients with SLE with secondary APS.
Thromboprophylaxis is recommended.
Patients should be evaluated for renal disease, (glomerulonephritis, end-stage renal disease), anemia, and thrombocytopenia.
Note the following:
The medications shown should not be used in the presence of contraindications.
Close obstetric monitoring of the mother and fetus is necessary in all cases.
The patient should be counseled in all cases regarding symptoms of thrombosis and thromboembolism.
Surgical Care
Patients with APS, especially secondary APS, may require surgical interventions for long-standing complications of their autoimmune disorder.
Cardiac valvular surgery is recommended in patients with severe aortic regurgitation due to the noninfectious vegetations that are seen as a result of APS.
Splenectomy is recommended in patients with the chronic form of idiopathic thrombocytopenic purpura and is associated with remission in approximately 75% cases.
Thromboprophylaxis is recommended for any abdominal or orthopedic surgery.
Manage thrombotic or hemorrhagic complications. Be aware of associated thrombocytopenia, and use laboratory methods of perioperative anticoagulation monitoring in the setting of prolonged clotting times.
Consultations
The patient should be informed about potential maternal and obstetric problems, including fetal loss, thrombosis or stroke, PIH, fetal growth restriction, and preterm delivery. Consultation with specialists in Maternal-Fetal Medicine and Rheumatology should be considered.
In women with APS and one or more prior thrombotic event, lifelong anticoagulation with warfarin may be advisable to avoid recurrent thrombosis. An assessment by a Rheumatologist or Hematologist may also be helpful.

Medication
In women with well-recognized obstetric APS, anticoagulant prophylaxis is recommended during pregnancy and the postpartum period. Pregnant women with APS are considered at risk for thrombosis and pregnancy loss. Data suggest low-dose aspirin and heparin (either unfractionated heparin or LMWH) are the treatments of choice for prevention of pregnancy loss in pregnant women with APS and previous pregnancy losses. Pregnant women with APS and a history of thrombosis but no pregnancy loss only require treatment with heparin. Treatment is optional for patients with no history of pregnancy loss or thrombosis.
Heparin compounds
Unfractionated intravenous (IV) heparin and fractionated subcutaneous (SC) LMWH are the 2 choices for initial anticoagulation therapy. Warfarin therapy may be initiated in the postpartum stage.
These are used in the treatment or prophylaxis of clinically evident intravascular thrombosis. Special precaution should be exercised in obstetrical emergencies or massive liver failure.
LMWHs may also be used. Similar to unfractionated heparin, LMWHs are a class of anticoagulants termed glycosaminoglycans. LMWHs are derived from unfractionated heparin but have smaller, more standard average masses than heterogeneous unfractionated heparin.
Unlike standard heparin, LMWHs have higher specificity for factor Xa and have fewer effects on platelet activity. As a result, LMWH may cause bleeding less often, while still retaining anticoagulant effects. LMWHs may be associated with less risk of heparin-induced osteoporosis.

Heparin, unfractionated
Indicated to decrease risk of thrombosis and pregnancy loss in pregnant women with APS.Augments activity of antithrombin III and prevents conversion of fibrinogen to fibrin. Does not actively lyse but is able to inhibit further thrombogenesis. Prevents reaccumulation of clot after spontaneous fibrinolysis.
Dosing
Adult
APS with prior fetal death/recurrent pregnancy loss: 15,000-20,000 U/d SC divided q12h plus low-dose aspirinAPS with prior thrombosis or stroke: Adjusted dose heparin SC q12h to maintain aPTT within target rangeAPS without prior pregnancy loss or thrombosis: 15,000-20,000 U/d SC divided q12h (treatment optional)
Pediatric
Adolescents: Administer as in adults
Interactions
Digoxin, nicotine, tetracycline, and antihistamines may decrease effects; NSAIDs, aspirin, dextran, dipyridamole, and hydroxychloroquine may increase toxicity
Contraindications
Documented hypersensitivity; subacute bacterial endocarditis, active bleeding, history of heparin-induced thrombocytopenia
Precautions
Pregnancy
C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus
Precautions
Hemorrhage, monitor aPTT, adjust dose accordingly; caution in severe hypotension and shock; heparin-induced osteoporosis

Enoxaparin (Lovenox)
Indicated to decrease risk of thrombosis and pregnancy loss in pregnant women with APS.Prevents DVT, which may lead to pulmonary embolism in patients undergoing surgery who are at risk for thromboembolic complications. Enhances inhibition of factor Xa and thrombin by increasing antithrombin III activity. In addition, preferentially increases inhibition of factor Xa.
Dosing
Adult
APS with prior fetal death/recurrent pregnancy loss: 40 mg/d SC plus low-dose aspirinAPS with prior thrombosis or stroke: 1 mg/kg SC q12hAPS without prior pregnancy loss or thrombosis: 40 mg/d SC (treatment optional)
Pediatric
Adolescents: Administer as in adults
Interactions
Platelet inhibitors or oral anticoagulants such as dipyridamole, salicylates, aspirin, NSAIDs, sulfinpyrazone, and ticlopidine may increase risk of bleeding
Contraindications
Documented hypersensitivity; major bleeding, thrombocytopenia
Precautions
Pregnancy
B - Fetal risk not confirmed in studies in humans but has been shown in some studies in animals
Precautions
If thromboembolic event occurs despite LMWH prophylaxis, discontinue drug and initiate alternate therapy; elevation of hepatic transaminases may occur but is reversible; heparin-associated thrombocytopenia may occur with fractionated or LMWH; 1 mg of protamine sulfate reverses effect of approximately 1 mg of enoxaparin if significant bleeding complications develop; heparin-induced osteoporosis; monitor target anti-Xa levels, adjust dose accordingly
Antiplatelet agents
Randomized controlled trials demonstrate improved fetal survival when pregnant women with APS and prior pregnancy losses are treated with low-dose aspirin plus heparin compared with low-dose aspirin alone.

Aspirin (Anacin, Ascriptin, Bayer Aspirin, Bayer Buffered Aspirin)
Antiplatelet effect indicated to decrease risk of thrombosis and pregnancy loss in pregnant women with APS. Inhibits prostaglandin synthesis, preventing formation of platelet-aggregating thromboxane A2. Used in low dose to inhibit platelet aggregation and improve complications of venous stasis and thrombosis.
Dosing
Adult
1-2 mg/d PO for antiplatelet effect; not to exceed 325 mg/d (low-dose aspirin)
Pediatric
Adolescents: Administer as in adults
Interactions
Effects may decrease with antacids and urinary alkalinizers; corticosteroids decrease salicylate serum levels; additive hypoprothrombinemic effects and increased bleeding time may occur with coadministration of anticoagulants; may antagonize uricosuric effects of probenecid and increase toxicity of phenytoin and valproic acid; doses > 2 g/d may potentiate glucose-lowering effect of sulfonylurea drugs
Contraindications

Precautions
Pregnancy
C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus
D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus
Precautions
May cause transient decrease in renal function and aggravate chronic kidney disease; avoid use in patients with severe anemia, with history of blood coagulation defects, or taking anticoagulants

Special Concerns
Regarding corticosteroid therapy, administer supplementation to cover the labor or cesarean delivery in patients currently receiving steroids or those recently treated with these drugs.
No evidence indicates adverse effects related to breastfeeding, although breastfeeding is not recommended if high doses of cytotoxic or immunosuppressive agents are required.
Pregnancy in itself is not harmful to the mother or the baby unless the added work related to the newborn and the emotional stress in the family prove to be too much for a particular patient. Therapeutic abortions are generally not indicated in pregnant women with autoimmune disease.
Epidural anesthetic is not recommended if the mother has a marked drop in the maternal platelet count.
The use of forceps or the vacuum extractor should be individualized.

PREMENSTRUAL SYNDROME

Introduction :
Premenstrual syndrome (PMS) is a diverse constellation of cyclic physical and emotional symptoms, occurring monthly during the luteal phase of the menstrual cycle (ovulation to menstruation). This phase is followed by a symptom-free period of at least 1 week, beginning after the onset of menses. Of all the symptoms, the emotional and behavioral symptoms are the most devastating. In an attempt to define and treat the psychological symptoms, the American Psychiatric Association has described premenstrual dysphoric disorder (PMDD). PMDD requires the presence of at least one of 4 core symptoms (irritability, dysphoria, labile mood, tension) and at least 5 of 11 other symptoms. Symptoms must markedly impair functioning and interfere with normal activities.
I. Incidence.
It has been reported that 70% to 90% of the female population will admit to recurrent menstrual problems. Between 20% and 40% report some degree of temporary mental and physical dysfunction and 2% to 5% may be incapacitated.
PMS is cross-cultural and affects women of all races, socioeconomic status, and professions. There may be an increased incidence with age and major life stresses. Demographic data are contradictory concerning genetic contribution, effects of number of pregnancies, and educational level. Women with severe PMS may have a lifetime increased incidence of affective disorders.
II. Etiology.
Evidence supports the association of PMS with abnormal neurotransmitter response to normal ovarian function. Recent research has confirmed that women with PMS have normal levels of both estrogen and progesterone, are not vitamin or mineral deficient, have normal prolactin and thyroid levels, and are euglycemic. Of the possible mediators of ovarian steroid action in the central nervous system, serotonin, gamma-amino butyric acid (GABA) receptors, and beta-endorphins are the best studied.
A. Serotonin.
The association of serotonin with mood and appetite disturbances is well documented, and the sex steroidal hormones do modulate serotonergic activity. Women with PMS have significantly lower serotonin levels during the luteal phase, as measured in peripheral blood, compared with normal controls. This may be due to impaired postsynaptic serotonergic response in PMS patients. Compounds that increase serotonin levels have been shown to decrease symptoms of PMS.
B. Beta-endorphin
levels may be lower in PMS patients during both the periovulatory and premenstrual phases of the menstrual cycle. Substances that increase beta-endorphins improve PMS symptoms.
C. GABA receptors
The GABA receptors, associated with control of anxiety, are stimulated by progesterone, which may be a mechanism in the modulation of anxiety in PMS.
III. History.
PMS is a polysymptomatic disorder and the syndrome may last anywhere from 3 to 21 days. Symptoms do not all begin on the same day nor will women have the same symptoms each month or throughout their lives. The following is a partial list of symptoms:
A. Behavioral symptoms:
depression, irritability, tension, lethargy, mood swings, anger, uncontrolled crying, aggression, panic attacks, anxiety, social withdrawal, change in memory or concentration, change in libido, poor impulse control.
B. Physical symptoms
-Neurologic: migraines and other headaches, syncope, vertigo.
EtiologyMetabolic: breast tenderness, edema.
-Cardiovascular: palpitations, ectopic beats, paroxysmal tachycardia.
-Gastrointestinal: nausea, abdominal bloating, flatulence, constipation, diarrhea.
-Urinary: oliguria, urethritis, cystitis, enuresis, urinary retention.
-Dermatologic: acne, urticaria.
-Musculoskeletal: pain and swelling of the joints and muscles.
C. Chronic medical problems,
such as diabetes and asthma, as well as psychological disorders may worsen premenstrually, a condition termed premenstrual magnification.
IV. Physical examination.
A complete physical examination including a pelvic examination is necessary to rule out other causes such as ovarian cysts, fibroids, pelvic inflammatory disease, endometriosis, and thyroid disease. It is also important to perform a complete mental status examination to rule out psychopathology. There are no characteristic physical findings of PMS.
V. Investigative procedures.
The diagnosis of PMS depends on the temporal relationship of psychological and somatic symptoms with menstruation rather than the presence of symptoms alone. It is the recurring symptoms during the luteal phase followed by a symptom-free time that defines PMS. A thorough medical, sexual, and psychological history as well as physical examination and laboratory studies are necessary to identify PMS and to rule out other disorders.
A. Menstrual chart.
Evaluation should include a detailed diary of symptoms charted against the menstrual cycle .
The chart should show the length of the menstrual cycle, duration of bleeding, and regularity or irregularity of menstruation. By definition, PMS occurs only during ovulatory cycles.
Each symptom along with its severity can be charted each day. The patient should be sure to include eating patterns if they vary with the cycle.
A full three cycles are optimal for evaluation.
Posthysterectomy patients may still experience PMS if they retained their ovaries, so their 3-month chart will show the same characteristic pattern.
B. Laboratory tests
should be ordered as indicated by history and/or examination to rule out other disease as a source of the patient's symptoms.
VI. Management.
Since PMS represents an abnormal response to the physiologic ovulatory cycle, management can be directed to:
Altering the cycle.
Changing the body's response to the cycle.
Treating the symptoms themselves.
A. Self-help steps
Education is one of the most important components in the management of PMS.
Knowledge of the menstrual cycle, as well as female anatomy and physiology can aid in understanding this disorder.
It is also helpful to read the available literature on PMS.
Keeping a menstrual chart helps a woman achieve awareness of her menstrual cycle as well as her premenstrual symptoms.
Exercise. Regular aerobic exercise at least three or four times per week, continuing through the premenstrual phase, may reduce symptoms of PMS. This is especially true of the physical symptoms including breast tenderness, fluid retention, and abdominal cramping. Exercise has been shown to reduce stress and anxiety, increasing one's sense of well-being.
Stress management. Women should be encouraged to reduce the demands that they make on themselves and on others. Relaxation, visualization, and hypnosis are some other important methods of stress reduction. Supportive psychotherapy and reflexology may also be beneficial .
Diet and nutrition improves one's overall feeling of health and may be helpful with PMS. Recommended dietary changes include increasing complex carbohydrates and green vegetables and decreasing simple sugars, fats, and processed foods. Unfortunately, specific studies of the effect of diet on PMS have not demonstrated a benefit, with the exception of eliminating caffeine, which helps reduce breast tenderness and low salt/low fat diet, which improves fluid retention.
B. Food supplements
Vitamin B6. Pyridoxine is a coenzyme in the biosynthesis of serotonin and dopamine, probable mediators of PMS. Some studies have shown a benefit with vitamin B6 in doses well above the recommended daily allowance (RDA), starting at 25 mg twice daily and increasing to 100 mg per day. Higher doses to 300 mg have been studied but carry a significant risk of peripheral neuropathy.
Vitamin E in doses of 400 to 600 IU/day has, in some studies, alleviated the symptom of breast tenderness associated with PMS.
Calcium improves symptoms of water retention, abdominal cramps, and mood changes in doses of 1,000 mg/day. One study has also shown improvement with food cravings.
Magnesium supplementation, 300 to 500 mg daily during the luteal phase, has been shown to improve symptoms of mood changes and fluid retention in small randomized crossover trials.
There are now many PMS formulae that combine vitamins and mineral supplements. Of these only a few, Lurline PMS tablets and Optivite have been studied and shown to have some efficacy.
The use of cis-linoleic acid (evening primrose oil), 1,500 mg bid, is an old remedy for depression and anxiety symptoms of PMS. Randomized, double-blind trials have been unable to substantiate its efficacy.
C. Drug therapy.
Drug therapy can be tailored to alleviate specific symptoms or to obliterate the menstrual cycle itself.
Oral contraceptive pills (OCPs) are often used as a first-line treatment for premenstrual symptoms but few studies have substantiated efficacy except with some physical symptoms such as cramps and bloating.
Monophasic preparations may be more effective than triphasic combinations.
Patients should be warned that psychological symptoms could worsen when taking OCPs.
In the past, progesterone was widely used for PMS, but well designed studies do not demonstrate efficacy. The general popularity of using progesterone for PMS may be due to its mildly sedative properties.
Synthetic progestins (medroxyprogesterone acetate, norethindrone) are used as contraceptives or to regulate menstrual flow.
In some women, medroxyprogesterone acetate (Depo-Provera) eliminates the menstrual cycle and can in this way improve some of the physical symptoms of PMS.
Progestins should be used with caution in women with PMS because they can exacerbate psychological symptoms, especially anxiety and depression.
Gonadotropin releasing hormone (GnRH) agonists obliterate the menstrual cycle and are therefore very effective in controlling symptoms of PMS. Randomized trials have demonstrated significant improvement in PMS symptoms; however, psychological symptoms are not as consistently improved as physical symptoms.
These medications are expensive and must be used with add-back estrogen and progesterone to reduce menopausal side effects such as osteoporosis.
Use of GnRH agonists without add-back hormonal replacement must be limited to less than 6 months.
Leuprolide acetate, 3.75 mg IM monthly OR 11.25 mg q 3 months OR
Goserelin, 3.6 mg SQ implant monthly, OR
Nafarelin, 200 g bid intranasally, are the most commonly used preparations.
Selective serotonin reuptake inhibitors (SSRIs) are highly effective in the treatment of severe PMS. Multiple controlled double-blind studies have shown efficacy, with resolution of symptoms nearly immediately and in smaller doses than is normally used for depression.
Fluoxetine has been studied in the most detail and is effective in doses as small as 5 mg and up to 20 mg po qd. Efficacy has been shown with a daily dose throughout the month and also with treatment only during the luteal phase of the menstrual cycle (i.e., with symptoms). Although generally well tolerated, side effects include insomnia, anxiety, gastrointestinal disturbances, and sexual dysfunction.
Paroxetine, 5 to 30 mg/day, and sertraline, 25 to 150 mg/day, have not been as extensively studied as fluoxetine for PMS but are probably equally as effective.
Clomipramine, a tricyclic antidepressant with serotonin and noradrenaline reuptake inhibiting properties, has been successfully used to treat severe psychological symptoms of PMS.
Effective doses are 25 to 75 mg PO qd during the luteal phase of the menstrual cycle.
Side effects including fatigue, weight gain, nausea, seizures, and dry mouth may limit its usefulness.
Anxiolytics
Buspirone may be useful in patients with predominant symptoms of anxiety and it is neither sedating nor habit forming. The initial dosage is 5 mg tid, gradually increasing to cessation of symptoms with a maximum dose of 60 mg/day.
Alprazolam controls anxiety and irritability if given during the symptomatic period.
However, its use is associated with sedation, tolerance, and dependence and it should be used cautiously.
Dosage is 0.25 mg tid, increasing to a total daily dose of 4 mg. At the beginning of menses, the dose should be decreased by 25% each day.
Diuretics. Abdominal bloating and water retention are some of the most common symptoms of PMS. Despite this, actual weight gain and change in total body water have not been well demonstrated in studies. In this light, diuretics should be used with caution. Spironolactone, 25 mg tid or qid, during the luteal phase of the menstrual cycle may be effective for abdominal bloating and also may improve irritability, depression, and food cravings.
Danazol, a synthetic androgen, is effective in suppressing symptoms of PMS. However, its side effects, including weight gain and virilization may be unacceptable to patients.
D. Surgery.
Bilateral oophorectomy is rarely indicated in PMS treatment and should be reserved only for patients with severe PMS and after failure of all conservative measures. Complete resolution should be demonstrated with GnRH agonist suppression prior to undertaking surgery. Consideration should also be made of the number of years left until menopause.

Premature Rupture of Membranes (PROM) , Dr. Alaa Mosbah ,MD OBS&GYN

Definition:
It is rupture of membranes before onset of labour(PROM) .
Also rupture of membrane before 37 weeks gestation is called PPROM
Incidence:
10% of term pregnancies .
Preterm PROM complicates approximately 3 percent of pregnancies and leads to one third of preterm births
Aetiology:
The following factors are incriminated:
1. Cervical incompetence.
2. Polyhydramnios.
3. Multiple pregnancy.
4.Malpresentations as the presenting part is not fitting against the lower uterine segment .
5. Chorioamnionitis.
6. Low tensile strength of the membranes.A decrease in the collagen content of the membranes has been suggested to predispose patients to preterm PROM
7.those who have lower socioeconomic status, are smokers, have a history of sexually transmitted infections, have had a previous preterm delivery
Diagnosis:
The diagnosis of PROM requires a thorough history, physical examination, and selected laboratory studies. Patients often report a sudden gush of fluid with continued leakage. Physicians should ask whether the patient is contracting, bleeding vaginally, has had intercourse recently, or has a fever.
1- History: of gush of fluid per vaginum that moists vulval pads.
Drawback: Vulval pads can be moisted with urine or vaginal
discharge which can be mistaken with the amniotic fluid.

2- Nitrazine paper test:
The colour turns from yellow to deep blue due to alkalinity of the
amniotic fluid.
Drawback: blood, semen or vaginal infection are alkaline media give the same result.
3- Laboratory analysis: for creatinine, urea and uric acid in the fluid
sample.
Drawback: these components are present in the urine.
4- Fern test:
Visualization of fern-like pattern of dried amniotic fluid on a glass
slide under microscopy due to presence of protein.
Drawback: protein may be present in urine.
5- Sterile speculum examination:
to observe the escape of amniotic fluid from the external os.
6- Dye injection:
Through abdominal needle under ultrasonic guide into the amniotic
sac and observation of its passage through the external os or even in
the vulval pad.
Drawback: It carries risk of foetal trauma particularly if a large
amount of the amniotic fluid was drained.
7- Vernex, meconium or alpha-fetoprotein detection:
in the fluid sample is diagnostic.
8- Ultrasound:
is an ideal non-invasive technique for the detection of the residual amount of amniotic fluid. Oligohydramnios is diagnosed if the measurement of the largest bocket of the amniotic fluid is 1 cm or less . The largest bocket is usually present between the anterior shoulder and the neck.Or amniotic fluid index less than 5 cm .

Complications:
1. Preterm labour: with the risk of prematurity.
2. Infection: chorio-amnionitis, septicaemia and foetal pneumonia.
3. Foetal deformities and distress: due to oligohydramnios.
Management:
(1) Gestational age over 36 weeks:
- In absence of infection, foetal distress and abnormal lie,
wait for 24 hours as about 90% of patients with PROM will
pass into spontaneous labour. Prophylactic antibiotic can be
given during this period.
- PGE2 and / or oxytocin is used for induction of labour in
patients did not pass into labour after 24 hours.
(2) Gestational age between 34-36 weeks:
- In absence of infection and foetal distress, wait for 48
hours as rupture of membrane itself will accelerates lung
surfactant production and hence lung maturity.
- Induce labour after 48 hours with PGE2 and /or oxytocins.
- Prophylactic antibiotics is given during this period.
- Caesarean section is indicated in breech presentation < 36
weeks’ gestation.
(3) Gestational age between 28-34 weeks:
In absence of infection, the main aim is to manage the case
conservatively till the 35th week when lung maturity mostly occurs
and the baby can survive.
Conservative management as follow:

i) Rest in bed as long as there is escape of liquor
with restriction of efforts later on particularly
those that increase intra-abdominal pressure.
ii) Temperature is recorded every 4 hours.
iii) Observation for malaise, abdominal pain,
uterine tenderness and amount of escaped liquor
on sterile vulval pads.
iv) Leucocytic count and C-reactive protein may
be done every other day.
v) Prophylactic antibiotics may be given although
this is not advised by some authors as it may lead
to colonisation of resistant strains of organisms in
the genital tract.
vi) Tocolytic drugs : are given if uterine activity
starts.
vii) Corticosteroid therapy: is given for 48 hours
if labour was imminent or will be induced before
35 weeks.
(4) Gestational age less than 28 weeks:
There is little chance of foetal survival and the condition is usually considered as inevitable abortion.

RECOMMENDATIONS
The following recommendations and conclusions are based on good and consistent scientific evidence (Level A):
For women with premature rupture of membranes (PROM) at term, labor should be induced at the time of presentation, generally with oxytocin infusion, to reduce the risk of chorioamnionitis.
Patients with PROM before 32 weeks of gestation should be cared for expectantly until 33 completed weeks of gestation if no maternal or fetal contraindications exist.
A 48-hour course of intravenous ampicillin and erythromycin followed by 5 days of amoxicillin and erythromycin is recommended during expectant management of preterm PROM remote from term to prolong pregnancy and to reduce infectious and gestational age-dependent neonatal morbidity.
All women with PROM and a viable fetus, including those known to be carriers of group B streptococci and those who give birth before carrier status can be delineated, should receive intrapartum chemoprophylaxis to prevent vertical transmission of group B streptococci regardless of earlier treatments.
A single course of antenatal corticosteroids should be administered to women with PROM before 32 weeks of gestation to reduce the risks of respiratory distress syndrome (RDS), perinatal mortality, and other morbidities.
The following recommendations and conclusions are based on limited and inconsistent scientific evidence (Level B):
Delivery is recommended when PROM occurs at or beyond 34 weeks of gestation.
With PROM at 32 to 33 completed weeks of gestation, labor induction may be considered if fetal pulmonary maturity has been documented.
Digital cervical examinations should be avoided in patients with PROM unless they are in active labor or imminent delivery is anticipated.
The following recommendations and conclusions are based primarily on consensus and expert opinion (Level C):
A specific recommendation for or against tocolysis administration cannot be made.
The efficacy of corticosteroid use at 32–33 completed weeks is unclear based on available evidence, but treatment may be beneficial particularly if pulmonary immaturity is documented.
For a woman with preterm PROM and a viable fetus, the safety of expectant management at home has not been established.
Table: Management of Premature Rupture of Membranes Chronologically

Gestational Age
Management
Term (37 weeks or more)
Proceed to delivery, usually by induction of labor
Group B streptococcal prophylaxis recommended
Near term (34 weeks to 36 completed)
Same as for term
Preterm (32 weeks to 33 completed weeks)
Expectant management, unless fetal pulmonary maturity is documented
Group B streptococcal prophylaxis recommended
Corticosteroid—no consensus, but some experts recommend
Antibiotics recommended to prolong latency if there are no contraindications
Preterm (24 weeks to 31 completed weeks)
Expectant management
Group B streptococcal prophylaxis recommended
Single-course corticosteroid use recommended
Tocolytics—no consensus
Antibiotics recommended to prolong latency if there are no contraindications
Less than 24 weeks*
Patient counseling
Expectant management or induction of labor
Group B streptococcal prophylaxis is not recommended
Corticosteroids are not recommended
Antibiotics—there are incomplete data on use in prolonging latency.

Definitions:
Grades of Evidence
I Evidence obtained from at least one properly designed randomized controlled trial.
II-1 Evidence obtained from well-designed controlled trials without randomization.
II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments could also be regarded as this type of evidence.
III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Levels of Recommendations
Level A — Recommendations are based on good and consistent scientific evidence.
Level B — Recommendations are based on limited or inconsistent scientific evidence.
Level C — Recommendations are based primarily on consensus and expert opinion.

American College of Obstetricians and Gynecologists (ACOG). Premature rupture of membranes. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2007 Apr. 13 p. (ACOG practice bulletin; no. 80). [103 references]

Partograph

Partograph
•A partograph is a graphical record of the observations made of a women in labour
•For progress of labour and salient conditions of the mother and fetus
•It was developed and extensively tested by the world health organization WHO
Friedman's partogram devised in 1954 was based on observations of cervical dilatation and foetal station against time elapsed in hours from onset of labour. The time onset of labour was based on the patient's subjective perception of her contractility. Plotting cervical dilatation against time yielded the typical sigmoid or 'S' shaped curve and station against time gave rise to the hyperbolic curve.
•The partograph can be used by health workers with adequate training in midwifery who are able to :
- observe and conduct normal labour and delivery.
- Perform vaginal examination in labour and assess cervical diltation accurately
- plot cervical diltation accurately on a graph against time
•There is no place for partograph in deliveries at home conducted by attendants other than those trained in midwifery
•Whether used in health centers or in hospitals , the partograph must be accompanied by a program of training in its use and by appropriate supervision and follow up
Objectives

•early detection of abnormal progress of a labour
• prevention of prolonged labour
• recognize cephalopelvic disproportion long before obstructed labour
•assist in early decision on transfer , augmentation , or terminjation of labour
• increase the quality and regularity of all observations of mother and fetus
• early recognition of maternal or fetal problems
•the partograph can be highly effective in reducing complications from prolonged labor for the mother (postpartum hemorrhage, sepsis, uterine rupture and its sequelae) and for the newborn (death, anoxia, infections, etc.).

•early detection of abnormal progress of a labour
• prevention of prolonged labour
• recognize cephalopelvic disproportion long before obstructed labour
•assist in early decision on transfer , augmentation , or terminjation of labour
• increase the quality and regularity of all observations of mother and fetus
• early recognition of maternal or fetal problems
•the partograph can be highly effective in reducing complications from prolonged labor for the mother (postpartum hemorrhage, sepsis, uterine rupture and its sequelae) and for the newborn (death, anoxia, infections, etc.).
Partograph function

•The partograph is designed for use in all maternity settings , but has a different level of function at different levels of health care
• in health center, the partograph,s critical function is
to give early warning if labour is likely to be prolonged and to indicate that the woman should be transferred to hospital (ALERT LINE FUNCTION )
• in hospital settings, moving to the right of alert line serves as a warning for extra vigilance , but the action line is the critical point at which specific management decisions must be made
•other observations on the progress of labour are also recorded on the partograph and are essential features in management of labour
Components of the partograph

•Part 1 : fetal condition ( at top )
•Pqrt 11 : progress of labour ( at middle )
•Part 111 : maternal condition ( at bottom )
.Outcome
Part 1 : Fetal condition

•this part of the graph is used to monitor and assess fetal condition
•1 - Fetal heart rate
•2 - membranes and liquor
•3 - moulding the fetal skull bonesCaput

Basal fetal heart rate?
•< 160 beats/mi =tachycardia
• > 120 beats/min = bradycardia
• >100 beats/min = severe bradycardia
Decelerations? yes/no
Relation to contractions?
n Early
n Variable
n Late – -----Auscultation - return to baseline
> 30 sec è contraction
----- Electronic monitoring
peak and trough (nadir)è > 30 sec
membranes and liquor

•intact membranes ……………………………………….I
•ruptured membranes + clear liquor …………………….C
•ruptured membranes + meconium- stained liquor ……..M
•ruptured membranes + blood – stained liquor …………B
•ruptured membranes + absent liquor…………………....A

moulding the fetal skull bones

•Molding is an important indication of how adequately the pelvis can accommodate the fetal head
•increasing molding with the head high in the pelvis is an ominous sign of cephalopelvic disproportion
•separated bones . sutures felt easily ……………….….O
•bones just touching each other ………………………..+
•overlapping bones ( reducible 0 ……………………...++
•severely overlapping bones ( non – reducible ) ……..+++

Part11 – progress of labour

Cervical diltation
•Descent of the fetal head
•Fetal position
•Uterine contractions
•this section of the paragraph has as its central feature a graph of cervical diltation against time
•it is divided into a latent phase and an active phase
latent phase :

•it starts from onset of labour until the cervix reaches 3 cm diltation
•once 3 cm diltation is reached , labour enters the active phase
•lasts 8 hours or less
•each lasting < 20 sceonds at least 2/10 min contractions

Active phase :

•Contractions at least 3 / 10 min
•each lasting < 40 sceonds
•The cervix should dilate at a rate of 1 cm / hour or faster

Alert line ( health facility line )

•The alert line drawn from 3 cm diltation represents the rate of diltation of 1 cm / hour
•Moving to the right or the alert line means referral to hospital for extra vigilance

Action line ( hospital line )

•The action line is drawn 4 hour to the right of the alert line and parallel to it
•This is the critical line at which specific management decisions must be made at the hospital

Cervical diltation

•It is the most important information and the surest way to assess progress of labour , even though other findings discovered on vaginal examination are also important
•when progress of labour is normal and satisfactory , plotting of cervical diltation remains on the alert line or to left of it
• if a woman arrives in the active phase of labour , recording of cervical diltation starts on the alert line
• when the active phase of labor begins , all recordings are transferred and start by pltting cervical diltation on the alert line

Descent of the fetal head

•It should be assessed by abdominal examination immediately before doing a vaginal examination, using the rule of fifth to assess engagement
•The rule of fifth means the palpable fifth of the fetal head are felt by abdominal examination to be above the level of symphysis pubis
•When 2/5 or less of fetal head is felt above the level of symphysis pubis , this means that the head is engage , and by vaginal examination , the lowest part of vertex has passed or is at the level of ischial spines

Assessing descent of the fetal head by vaginal examination; 0 station is at the level of the ischial spine (Sp).

Uterine contractions

•Observations of the contractions are made every hour in the latent phase and every half-hour in the active phase
• frequency how often are they felt ?
• Assessed by number of contractions in a 10 minutes period
• duration how long do they last ?
Measured in seconds from the time the contraction is first felt abdominally , to the time the contraction phases off
•Each square represents one contraction
Palpate number of contraction in ten minutes and duration of each contraction in seconds

Part111: maternal condition

Name / DOB /Gestation
Medical / Obstetrical issues
Assess maternal condition regularly by monitoring :
•drugs , IV fluids , and oxytocin , if labour is augmented
• pulse , blood pressure
•Temperature
• Urine volume , analysis for protein and acetone

USING THE PARTOGRAPH POINTS TO REMEMBER

•It is important to realize that the partograph is a tool for managing labor progress only
•The partograph does not help to identify other risk factors that may have been present before labor started

•only start a partograph when you have checked that there are no complications of pregnancy that require immediate action
•a partograph chart must only be started when a woman is in labor,-- be sure that she is contracting enough to start a partograph
•if progress of labor is satisfactory , the plotting of cervical diltation will remain or to the left of the alert line

•when labor progress well , the diltation should not move to the right of the alert line
•the latent phase . 0 – 3 cm diltation , is accompanied by gradual shortening of cervix . normally , the latent phase should not last more than 8 hours
•the active phase , 3 – 10 cm diltation , should progress at rate of at least 1 cm/hour
•when admission takes place in the active phase , the admission diltation, is immediately plotted on the alert line

•when labor goes from latent to active phase , plotting of the diltation is immediately transferred from the latent phase area to the alert line

•diltation of the cervix is plotted ( recorded with an X , desent of the fetal head is plotted with an O , and uterine contractions are plotted with differential shading
•desent of the head should always be assessed by abdominal examination ( by the rule of fifths felt above the pelvic brim ) immediately before doing a vaginal examination
•assessing descent of the head assists in detecting progress of labor
•increased moulding with a high head is a sign of cephalopelvic disproportion

•vaginal examination should be performed infrequently as this is compatible with safe practice ( once every 4 hours is recommended )
•when the woman arrives in the latent phase , time of admission is 0 time
•a woman whose cervical diltation moves to the right of the alert line must be transferred and manged in an institution with adequate facilities for obstetric intervention , unless delivery is near

•when a woman ,s partograph reaches the action line , she must be carefully reassessed to determine why there is lack of progress , and a decision must be made on further management ( usually by an obesterician or resident )
•when a woman in labor passes the latent phase in less than 8 hours i.e., transfers from latent to active phase , the most important feature is to transfer plotting of cervical diltation to the alert line using the letters TR,
•Leaving the area between the transferred recording blank. The broken transfer line is not part of the process of labor
do not forget to transfer all other findings vertically

Abdominal Incisions and Sutures in Gynecologic Surgery

Location and type :
Abdominal incisions for gynecologic surgery requires consideration of several factors. These factors include the disease process, patient’s weight, operative exposure, simplicity, and speed of the procedure. The most important factor is adequate exposure to the operative field. Complications during surgery can occur due to inadequate exposure, which often is due to the unwillingness of the surgeon to extend the incision. Incision location is particularly important when the patient has a gynecologic malignancy. These patients may need a colostomy, urinary diversion, or extraperitoneal lymph node dissection to satisfactorily treat their disease. This article reviews pertinent abdominal wall anatomy, discusses various options for abdominal incisions, and examines various sutures available to surgeons.
Anatomy :
A thorough understanding of abdominal wall anatomy is essential for choosing and making the proper surgical incision. The musculature of the abdominal wall is composed of 2 groups of muscles. One group, the flat muscles, consists of the external oblique, internal oblique, and the transversus abdominis. The second group is composed of 2 muscles that run vertically, the rectus abdominis and the pyramidalis.
The external oblique muscle is the largest and most superficial of the flat muscles of the abdominal wall. Arising from the lower 8 ribs, the external oblique courses transversely to insert upon the iliac crests. The aponeurosis is a strong tendinous sheath that ends medially in the linea alba. The internal oblique muscle arises from the upper surface of the inguinal ligament, the iliac crest, and the thoracolumbar fascia. This muscle courses at a right angle to the fibers of the external oblique muscle. The aponeurosis of the internal oblique splits at the edge of the rectus muscle to envelope the rectus. The anterior layer blends with the aponeurosis of the external oblique. Posterior to the rectus muscle, this aponeurosis blends with the aponeurosis of the transversus abdominis to form a portion of the posterior rectus sheath.
The innermost of the flat muscles is the transversus abdominis. This muscle arises from the inguinal ligament, the iliac crest, the thoracolumbar fascia, and the lower costal cartilages. Coursing transversely to the midline, the upper three fourths of the transversus aponeurosis lies behind the rectus muscle. The lower one fourth of the aponeurosis passes in front of the rectus muscle. The aponeurosis of each flat muscle joins medial to the rectus muscle to form the linea alba.
Originating from the pubic crest, the rectus muscle runs vertically to insert into the xiphoid process and the fifth, sixth, and seventh costal cartilages. The muscle fibers contain 3 fibrous insertions known as the linea transversae. The rectus is surrounded by the rectus sheath, which consists of the aponeuroses of the oblique muscles and the transversus abdominis. A small, vestigial, triangular-shaped muscle, the pyramidalis, arises from the symphysis and inserts upon the linea alba. This muscle marks the midline and assists in the identification of the medial borders of the rectus muscle.
Two important surgical landmarks are formed by the aponeuroses of the muscles of the abdominal wall. The linea alba is in the midline between the 2 rectus muscles. Formed by the fusion of the aponeuroses of the external oblique, internal oblique, and transversus abdominis, identifying this structure during a midline incision is important. A second surgical landmark is the arcuate line that is found below the rectus muscle, approximately halfway between the umbilicus and the symphysis pubis. Above the arcuate line, the aponeuroses of the internal oblique and transversus abdominis fuse to form the posterior rectus sheath. Below the arcuate line, the posterior rectus sheath is absent. This anatomic finding occurs as the aponeuroses of the oblique muscles and the transversus pass in front of the rectus muscle.
Blood supply
The primary blood supply to the abdominal wall is from the inferior and superior epigastric arteries, the deep circumflex arteries, and the musculophrenic arteries. The inferior epigastric artery originates from the external iliac artery and courses posterior to the lateral one third of the rectus muscle. Another branch of the external iliac is the deep circumflex artery, which courses cephalad lateral to the inferior epigastric artery. The superior epigastric artery is the terminal branch of the internal thoracic artery. This artery has multiple branches leading to the rectus muscle and has an anastomosis with the inferior epigastric artery. The internal thoracic artery is the source of the musculophrenic artery, which has an anastomosis with the deep circumflex artery. A larger network of vascular anastomoses exists in the abdominal wall and provides an excellent blood supply to all areas of the abdominal wall.
Nerve supply
Innervation of the abdominal wall is by the thoracoabdominal nerves, the ilioinguinal nerves, and the iliohypogastric nerves. The thoracoabdominal nerves travel caudad between the transversus abdominis and the internal oblique. These nerves innervate the flat muscles of the abdominal wall and the rectus muscle. Innervating the lower abdominal wall are the iliohypogastric nerves and the ilioinguinal nerves. Both of these nerves arise primarily from the first lumbar nerve root. Damage to these nerves results in sensory changes in the mons pubis and the labia majora.
Types of abdominal incisions :
Vertical incision
Several types of vertical abdominal incisions have been used in gynecologic surgery, including midline, paramedian, and wide paramedian incisions. A midline incision is almost exclusively the type of vertical incision used in gynecologic oncology surgery. The midline incision is the easiest and most versatile vertical incision for performing gynecologic cancer surgery. This incision allows quick entry into the abdominal cavity with little blood loss, and it easily can be extended in length to accommodate the operative findings. The disadvantages of this incision include an increase risk of wound dehiscence and hernia formation (compared to a transverse incision).
For a midline incision, the skin and subcutaneous fat is incised down to the level of the fascia. The scalpel or electrocautery can be used to incise this tissue. Some surgeons believe the infection rate is higher with the use of electrocautery, but randomized control trials comparing these 2 techniques are lacking. Using either instrument, the principle is to make long smooth strokes through the subcutaneous fat to the fascia. Do not dissect the subcutaneous fat from the fascia because this creates unnecessary dead space. Next, the fascia is incised and the rectus muscles separated vertically in the midline. The midline may not be evident in patients with previous abdominal surgery. Identifying where the rectus muscles diverge around the umbilicus or locating the pyramidalis muscles assists in identifying the midline. Once the rectus muscles are divided, the peritoneum is grasped between 2 hemostats, opened with a scalpel, and extended the length of the incision.
If the operative findings necessitate extending the incision above the umbilicus, avoid cutting through the umbilicus. Postoperative wound infections may be increased due to bacterial colonization of the umbilicus. Extension of the incision should pass to the left of the umbilicus to avoid cutting through the ligamentum teres.
Closure of the midline incision has evolved over the last 2 decades. Layered closure using interrupted sutures previously was the choice of many surgeons. Today, many surgeons prefer to close the abdominal wall using a continuous running suture. The use of a continuous suture to close the fascia is faster, with dehiscence rates comparable to interrupted closures. Two basic techniques are used to close the abdomen with continuous suture, the single-layer mass closure and the internal mass closure. The single-layer mass closure involves using a heavy monofilament delayed-absorbable or permanent suture. Fascial closure involves penetrating the fascia 1.5 cm from the edge with the suture. The suture also should include the underlying muscle and peritoneum.
Some surgeons close the wound using the internal mass closure technique advocated by Smead-Jones. This is a far-far, near-near suturing technique. The anterior fascia is included in the near-near bite. The initial stitch is similar to the single-layer mass closure. The second bite only includes the anterior rectus fascia, approximately 0.5 cm from the fascial edge. Either technique requires starting from each end of the incision. Securing the suture with 5 knots at each end is sufficient. In thin patients, burying the knot is helpful. Some surgeons place a small hemoclip above each knot to prevent unraveling.
Transverse incision
Several useful transverse abdominal incisions are available to the surgeon performing gynecologic cancer surgery. Historically, the obstetrician-gynecologist has preferred this type of incision. Reported advantages include better cosmetic results, less pain, and low incidence of hernia formation. Gynecologic oncologists have embraced certain types of transverse incisions for specific gynecologic cancer operations. However, several disadvantages to the transverse incision exist. These incisions limit exploration of the upper abdomen, are associated with greater blood loss, and are more prone to hematoma formation when compared to a midline incision. An increased risk of injury to nerves innervating the area also exists, thus leading to subsequent anesthesia of the overlying skin.
Pfannenstiel incision
The Pfannenstiel incision results in good exposure to the central pelvis but limits exposure to the lateral pelvis and upper abdomen. These factors limit the usefulness of this incision for gynecologic cancer surgery. If the patient is thin and has a gynecoid or platypelloid pelvis, this incision can be used for a radical hysterectomy and pelvic lymph node dissection.
The incision usually is made 1-2 fingerbreadths above the pubic crest. Use of a marking pen is helpful to keep the incision symmetric. An incision length of 10-14 cm is sufficient. Increasing the length of the skin incision usually does not improve exposure due to the rectus muscles. The incision is made through the subcutaneous fat to the fascia. The superficial epigastric vessels often are near the lateral edges of the incision.
The anterior fascia is incised in the midline with a scalpel. Using curved scissors or electrocautery, the fascia is incised in a curvilinear fashion 1-2 cm lateral to the rectus muscle. The upper edge of the fascia is grasped with 2 Kocher clamps on either side of the midline. Using electrocautery, the rectus muscle is dissected free from the fascia. Electrocautery allows coagulation of multiple small vessels that perforate the rectus muscle to the fascia. The rectus muscles are mobilized off the fascia to the level of the umbilicus. Next, the lower fascial edge is grasped with Kocher clamps. Electrocautery is used again to dissect the rectus muscles and the pyramidalis muscle from the fascia. The rectus muscles are separated. The peritoneum is opened and incised vertically to complete a Pfannenstiel incision.
Closure of the Pfannenstiel incision is straightforward. The peritoneum is closed with an absorbable suture. Some surgeons elect not to suture this layer, citing little information clearly indicating a benefit. Regardless of whether the peritoneum is closed, thoroughly irrigate the rectus muscles with water or saline, and cauterize or ligate any bleeding areas. Bleeding from small perforating vessels through the rectus muscle is the most common source of subfascial hematoma. The fascia is approximated with an absorbable suture. Usually, a separate suture is started at each end of the fascial incision, and they incorporate all layers of the anterior rectus sheath. Unless a large area of dead space exists between the fascia and skin, closure of the Scarpa fascia is not needed.
Maylard incision
In an effort to improve surgical exposure to the lateral pelvic sidewall with a transverse incision, Maylard proposed a transverse muscle-splitting incision. This incision usually refers to a subumbilical transverse incision. For gynecologic surgery, the incision is made 3-8 cm superior to the pubis symphysis. The anterior rectus sheath is cut transversely. The inferior epigastric vessels are identified under the lateral edge of each rectus muscle. After ligating these vessels, the rectus muscles are incised transversely with electrocautery. The peritoneum is opened and cut laterally.
To facilitate closure of a Maylard incision, flex the operating table. Close the peritoneum with an absorbable suture. Next, inspect the ties placed on each inferior epigastric vessel, and irrigate with water. Examine the cut edges of the rectus muscles for any bleeding areas. The fascia and underlying rectus muscle can be closed with a monofilament absorbable suture.
Cherney incision
Cherney described a transverse incision that allows excellent surgical exposure to the space of Retzius and the pelvic sidewall. The skin and fascia are cut in a manner similar to a Maylard incision. The rectus muscles are separated to the pubis symphysis and separated from the pyramidalis muscles. A plane is developed between the fibrous tendons of the rectus muscle and the underlying transversalis fascia. Using electrocautery, the rectus tendons are cut from the pubic bone. The rectus muscles are retracted and the peritoneum opened.
Closing a Cherney incision begins with closure of the peritoneum. Attach the cut ends of the rectus muscle to the distal end of the anterior rectus sheath with interrupted nonabsorbable sutures. Fixing the rectus muscle to the pubis symphysis can result in osteomyelitis. Next, the fascia is closed with 2, running, continuous, delayed-absorbable sutures.
Several types of incisions facilitate extraperitoneal paraaortic lymph node dissection. An upper abdominal transverse incision, which is a high Maylard incision, is made approximately 2 cm above the umbilicus. The incision is extended laterally and caudad to the anterior superior iliac spines. The fascia and rectus muscles are incised transversely, usually requiring ligation of the inferior and superior epigastric vessels. Next, the transversus abdominis muscle is cut, exposing the peritoneum. Using blunt dissection, the peritoneal sac is dissected caudad to cephalad to expose the psoas muscle, the aorta, and the common iliac vessels. Often, a drain needs to be placed in the area of the lymph node dissection.
Modified Gibson incision
Some gynecologic oncologists perform an extraperitoneal lymph node dissection using a modification of the Gibson incision. This incision can be made on each side of the midline, but often, the skin is cut only on the left. The incision is started 3 cm superior and parallel to the inguinal ligament. Extension is made vertically 3 cm medial to the anterior superior iliac spine to the level of the umbilicus. The fascia is cut and the peritoneum bluntly dissected, as described above. The round ligament and the inferior epigastric vessels are ligated to facilitate surgical exposure. Care is needed when exposing the lymph nodes using only a left-sided incision. Too much traction on the peritoneum can result in avulsion of the inferior mesenteric vessels.
Incisions in obese patients :
Surgery in patients who are obese and morbidly obese represents a challenge for every surgeon. Wound complication rates uniformly are higher in patients who are obese, regardless of the type of incision. Obtaining adequate surgical exposure requires patience, understanding of changes in anatomical landmarks, and proper surgical equipment.
The abdominal wall landmarks are distorted in patients who are obese, particularly if a large panniculus is present. The umbilicus is located caudad to its normal position. If a vertical incision is needed, first pull the panniculus downward. A periumbilical incision is made and the fascia incised to the symphysis. Care is needed not to buttonhole the skin under the panniculus. Use of a ring retractor, such as the Bookwalter, optimizes surgical exposure.
The site of a transverse incision in patients who are obese should never be made under the fold of the panniculus because wound infection rates are invariably higher. Make a transverse incision close to the umbilicus. However, in some patients, this incision may be too far from the pelvic organs. The surgeon may find the distance to the pelvic structures exceeds the length of the surgical instruments and the retractors. In this scenario, perform a panniculectomy. A panniculectomy allows the fascial incision to be within several centimeters of the pubis symphysis, allowing easier access to the pelvic organs. Place large suction drains above the fascial closure with a panniculectomy, and keep them in place until the drainage is less than 25 cc in 24 hours.
Sutures :
A suture is any strand of material used to approximate tissue or ligate vessels. Various materials have been used for sutures throughout history. Materials incorporated into sutures include horsehair, linen, silk, animal intestines, and wire. The ideal suture has yet to be created. Qualities important in a suture include uniform tensile strength, knot security, nonallergenic properties, and high tensile-strength retention during wound healing. Choosing the correct suture requires knowledge of the healing characteristics of tissues and understanding of the physical properties of various suture materials.
Absorbable sutures
Today, sutures are classified based on their absorptive properties. Absorbable sutures are prepared from the collagen of animals or synthetic polymers. These sutures are removed from the body by enzymatic action or hydrolysis. The ability of the suture to retain tensile strength dictates where the suture should be used in wound closure. Do not confuse the loss of tensile strength with the rate of absorption. Sutures can maintain adequate tensile strength until wound healing is complete, followed by rapid absorption. Conversely, some sutures may lose tensile strength rapidly and undergo slow absorption. All absorbable sutures eventually completely dissolve.
Absorbable sutures have some limitations. For patients with fever, infection, or poor nutritional status, absorption of absorbable suture may accelerate and lead to premature diminution of tensile strength. If these sutures are exposed to significant moisture, such as ascites, absorption rates are accelerated. The common absorbable sutures used in gynecologic surgery are as follows:
Surgical gut
Plain
Chromic
Fast absorbing
Polyglactin 910 (Vicryl)
Uncoated
Coated
Polyglycolic acid (Dexon)
Poliglecaprone (Monocryl)
Polydioxanone (PDS)
Polyglyconate (Maxon)
Poly (L-lactide/glycolide)(Panacryl)
Surgical gut sutures can be used to reapproximate mucosal surfaces or peritoneal edges, but they lack the tensile strength for use in fascial closure.
Synthetic absorbable sutures are used extensively in most gynecologic surgeries. Polyglactin (Vicryl) and polyglycolic acid (Dexon) often are used during a hysterectomy. These 2 sutures retain enough tensile strength to be used in fascial closure. Poliglecaprone 25 (Monocryl) is a newer absorbable suture that retains 50% of its tensile strength after 2 weeks.
Two monofilament absorbable sutures useful in fascial closure are polyglyconate (Maxon) and polydioxanone (PDS). Both of these sutures invoke little tissue reaction and maintain 50% of their tensile strength at 4 weeks. These sutures often are used with midline incision closures, especially in patients with cancer or other major comorbidities. Poly (L-lactide/glycolide) (Panacryl) is a new absorbable suture that is useful in patients with delayed wound healing. At 40 weeks, these sutures retain 50% of their tensile strength.
Nonabsorbable sutures
Enzymatic activity or hydrolysis does not digest nonabsorbable sutures. These sutures are composed of multiple filaments of metal, synthetic fibers, and organic fibers fashioned into a strand by twisting, braiding, or spinning. The commonly used nonabsorbable sutures are as follows:
Natural
Silk
Cotton
Stainless-steel wire (Flexon)
Nylon (Dermalon, Surgilon)
Polypropylene (Prolene, Novofil)
Braided synthetics (Dacron, Tevdek)
Use of nonabsorbable sutures, polypropylene (Prolene) or polybutester (Novofil), is recommended to close the fascia in the presence of infection. Tie these sutures with at least 6 throws.

CONTRACEPTION

Introduction :
The contraceptive user has an array of methods from which to choose. Appropriate considerations include the user's age, need for concomitant protection against sexually transmitted infections, future plans for childbearing, health status, pattern of sexual activity, and feeling about method options. Method safety and efficiency are usually the two issues of greatest concern for users and clinicians. The morbidity for any methods of contraception is low.
The important trends in ensuring the safest possible use of contraception include the following:
Use of low-dose oral contraceptive products (i.e., ≤35 µg of estrogen, low-potency progestin).
Use of long-lasting progestins when estrogen may not be safely used.
Proper patient selection for the intrauterine device (IUD).
Use of barrier methods to decrease risk of sexually transmitted disease (STD), HIV, and hepatitis B virus transmission are sometimes used in addition to other contraceptives.
Careful counseling concerning sterilization including counseling the partner on the safety of vasectomy.
Use of emergency contraception (EC): postcoital.
Early recognition and diagnosis of pregnancy and ectopic pregnancy.
I. Oral contraceptives :
are the second most commonly used method overall and the most common method for patients younger than 30. The pill has undergone substantial changes since its development in the 1950s. Most important is the reduction in the amount of estrogen. Initially, pills contained 40 to 80 µg of ethinyl estradiol, whereas today 30 to 35 µg is the standard. This reduction of estrogen almost eliminates concern about cardiovascular risk in healthy nonsmoking women. Cardiovascular risk seems to be related to the thrombotic effect of estrogen, which is dose-related. At 35 µg the risk is not any higher than the baseline risk of a healthy woman. Figure 22.1 is a chart on relative potency of estrogens and progestins in currently available oral contraceptives.
A. Types of pills
Combined pills when used perfectly have a very low failure rate of approximately 0.1% to 3.0%. They provide a daily dose of estrogen and progestin for 21 days in a 28-day cycle. Almost all pills today are comparable in efficacy, side effects, and complications.
Estrogen acts by inhibiting FSH production and decreasing follicle development thereby limiting ovulation. It also may prevent implantation and potentiates the effects of progestins. Estrogen also stabilizes the endometrium.
Progestins inhibit luteinizing hormone (LH) release and, therefore, can interfere with ovulation. The endometrium atrophies, the cervical mucus becomes thick and hostile to sperm, and the fallopian tubes have decreased motility. Bleeding occurs when the estrogen and progestin are withdrawn, usually during the last 7 days of the 28-day cycle.
There are several different progestins used in oral contraceptives.
They are of varying potency but in each formulation potency is compensated by the dosage.
Progestins have an androgenic pharmacology and may affect lipid levels adversely; however, clinically this is rarely a problem.
Of the progestins, norethynodrel may produce estrogenic effects, and norethindrone acetate and norgestrel may produce antiestrogenic or androgenic effects or both. There had been some concern that the so-called newer progestins (gestodene, desogestrel, and norgestimate) present in third generation OCPs may incur higher thromboembolic risks. However, more recent data does not support this hypothesis .
Multiphasic preparations contain varying daily dosages of estrogen and progestin. Theoretically, this decreases the progestin dose and androgenic effects. Clinically, however, there is very little difference between the monophasic and multiphasic preparations.
The minipill contains progestin only and is taken continuously at the same time of day and with no cyclic interruption for maximum effectiveness. The preparation's main effects are on the endometrium, cervix, and fallopian tubes.
Failure rates of the minipill when it is used correctly are only slightly higher than combination pills, 0.5% to 3.0%.
It causes anovulation in only 40% to 60% of users.
Since the minipill has no estrogen, it is recommended for women who have a contraindication to the combined pill .
Minipills are often well tolerated by women who experience side effects, such as headaches, when using combined pills.
It is likely that some noncontraceptive benefits of pills, such as protection against pelvic inflammatory disease (PID), are mediated by progestin.
B. Contraindications and risk factors.
Certain systemic conditions contraindicate the use of the pill.
Women with absolute contraindication should never be given the pill.
For those with strong relative contraindications, risk and benefits should be weighed carefully.
C. Evaluation issues
When discussing options with the patient, it is important to determine whether or not she has any of the risk factors. It is also important to discuss lifestyle issues, noncontraceptive benefits, side effects, and severe complications. Recent evidence has confirmed that combined oral contraceptives are extremely safe. Some authors have suggested that pills should be available over-the-counter without a prescription.
Noncontraceptive benefits. The pill offers many benefits other than contraception and is used in the treatment of several clinical conditions. The following is a summary of these benefits:
Decreased menstrual flow, dysmenorrhea, and anemia.
Decreased fibrocystic changes of the breast with prolonged use.
Decreased risk of PID, although the risk of cervicitis may be increased.
Decreased acne.
Decreased ovarian and endometrial cancer risks. The risk of breast cancer may be slightly increased but tumors, when found, tend to be diagnosed earlier and are of a less aggressive type .
Decreased risk of ovarian cysts, although this may not be as true with the low-dose pills.
Decreased risk of rheumatoid arthritis.
Fewer ectopic pregnancies and abortions owing to its contraceptive effectiveness.
Lifestyle and other issues.
It must be stressed that pills do not provide protection from STDs, HIV, or hepatitis B transmission. Patients who are not mutually monogamous should be encouraged to also use a barrier method with the pill.
Family history should be explored to determine if occult risk factors exist .
Discussions with patients will reveal fears and misinformation that the clinician can correct.
A good understanding of the pill's benefits, risks, and method of use will increase compliance and effectiveness.
D. Dosage and type.
The axiom for determining pill dosage is to use the lowest dosage that provides effective protection from pregnancy.
Most women should be prescribed a 35-µg or less estrogen pill.
These pills contain the more potent ethinyl estradiol and may not have a markedly lower estrogenic effect than do pills containing 50 µg of mestranol.
Spotting or failure to have withdrawal bleeding are common problems associated with use of low-dose pills. Patients should be warned of these problems and advised that they often spontaneously resolve after three cycles.
Pills containing more than 50 µg estrogen (80 or 100 µg) are for the most part unavailable now. Pills containing 50 µg estrogen may occasionally be appropriate for women with severe acne, dysfunctional bleeding, or endometriosis.
Progestin-only pills may be the initial pill choice for postpartum or nursing mothers, women older than 30 to 35 years, or women who have vascular headaches.
The minipill is also a good choice for women who do not tolerate combined pills or for those who develop relative contraindications to the use of combined pills.
E. Instructions
Clinicians.
A thorough history including the foregoing risk factors, lifestyles, and considerations must be obtained.
A thorough examination including blood pressure, breast examination, Papanicolaou (Pap) smear and pelvic examination is done.
Be sure that every pill user is aware of the pill danger signs .
New users may benefit from an initial follow-up visit at 3 months to check blood pressure and review problems. Most users who discontinue use do so because of side effects. Thus, it is very important to emphasize that most of these side effects resolve spontaneously within the first 3 months of use .
Thereafter, annual examinations and Pap smears are appropriate.
For women older than 35 who may have risk factors, a blood sugar concentration and lipid panel should be checked. Healthy women with no family history do not need these tests.
Documentation of counseling and examination findings is essential.
It is important that the patient fully understands the method of taking the pill, the side effects, and the severe complications. She should know when and whom to call with any questions.
Patients.
Every pill user should memorize the five pill danger signs. The first letter of each symptom spells the acronym ACHES:
Abdominal pain.
Chest pain or shortness of breath.
Headaches.
Eye problems, such as blurred vision, flashing lights, or blindness.
Severe leg pain.
A pill user who develops a breast lump, notices growth or change in a mole, develops liver disease or jaundice, or becomes depressed should contact her clinician.
Pill users should know how to report problems to the clinician and know what to do if they experience bleeding, skip a period, or forget to take one or more pills.
A new pill user should start the first pack of pills within the first 5 days of menses.
Most can start on a Sunday, which makes it easy to remember and relegates menses to the weekdays.
If she cannot start within the first 5 days, a backup method for the first full cycle should be used.
Starting a package beyond the first 6 to 7 days may increase the failure rate.
In adolescents with a negative pregnancy test, an immediate start may be helpful to prevent forgetfulness. A backup method must be used for the first cycle.
Patients should take one pill a day at about the same time of day.
F. Sequelae
Pill hormones affect virtually every organ system, and about 40% of users notice side effects or noncontraceptive benefits. Severe complications are rare.
Complications and side effects. The major complications of pills are cardiovascular. These, however, are primarily limited to women older than 35 who smoke or have a history of other cardiovascular problems or diabetes.
Life-threatening complications:
Thrombophlebitis.
Deep pelvic vein thrombosis.
Pulmonary embolism.
Arterial thromboembolic events resulting in cerebrovascular accident or myocardial infarction.
Hepatic adenomas. These may regress after discontinuation of the pill.
Serious side effects include:
Hypertension.
Gallbladder disease.
Vascular headache.
Depression.
Other minor side effects, which usually improve with time, include:
Nausea.
Weight gain.
Breast tenderness.
Breakthrough bleeding.
Decreased libido.
Women who develop acne may want to discontinue use or change to formulations with lower androgen-potency progestins. Orthotricycline has been approved to treat acne.
Higher rates of cervical neoplasia (dysplasia, carcinoma in situ, and invasive carcinoma) have been reported for pill users. Whether this is an effect of the pill or of lifestyle is unclear. The pill can be continued with very careful follow-up.
Pill effects on subsequent fertility.
Resumption of ovulation is usually within the first 14 to 21 days of discontinuing the pill.
The pregnancy rate in the first 3 months lags behind that of users of other methods. However, within a year the rates are relatively the same.
There is no indication that infertility is increased by the pill.
Older data indicate that the higher dose pill may have caused a pregnancy rate lag of up to 42 months.
Noncontraceptive benefits. Use of the pill is associated with a decreased incidence of PID, ovarian and endometrial cancer, ectopic pregnancy, iron-deficiency anemia, rheumatoid arthritis, ovarian functional cysts, benign breast lumps, dysmenorrhea, and acne .
G. Clinical dilemmas
Optimal management of pill problems involves numerous clinical dilemmas.
Forgotten pills.
A woman who forgets to take one pill should double up the next day.
If two pills are missed, she should double up for 2 days and use a backup method of birth control until the next menstrual period.
If three or more pills are missed, the user should start a new pack of pills and use a second method of contraception as well.
If she is a Sunday starter, she may continue the pills until Sunday and then start a new package.
Breakthrough bleeding is a common occurrence in the first 3 months of starting the pill. If breakthrough bleeding persists beyond that time, a different formulation may be tried or a small amount of estrogen may be added in the first 7 days of the cycle (1.25 mg of conjugated estrogens or 1 mg of estradiol).
Skipped periods or amenorrhea. The pill's effect on the endometrium is dominated by progestin and causes atrophy. Amenorrhea may be a response to continued progestin stimulation.
If the patient takes the pills regularly and she is not concerned about the lack of a “withdrawal period,” nothing need be done. It may be advisable to check a pregnancy test, if there is any doubt about whether the pills are taken correctly.
If the patient is concerned, a period may be induced by adding estrogen, 1.25 mg of conjugated estrogens or 1 mg of estradiol for 21 days of the cycle. This can be done for one or two cycles to thicken the endometrial lining.
Alternatively, a patient may be switched to an oral contraceptive with a lower progestin potency.
Development of vascular headaches, hypertension, or cholestasis are reasons to discontinue the pill.
Development of cervical dysplasia is not a reason to discontinue the pill. Pap smear or colposcopy surveillance is necessary. These patients may be at risk for other STDs, HIV, and hepatitis B transmission and should be counseled to use a barrier method as well as the pill.
H. Special considerations
Adolescents may benefit in many ways by using the pill.
Cycles are regulated, are less painful, and have decreased blood loss.
There is less risk for PID, although the pill does nothing to mitigate against STDs, HIV, and hepatitis B transmission.
Adolescents who are not mutually monogamous should use a barrier method in addition to the pill.
Women older than 35 who are perimenopausal benefit from pill use.
The pill will regulate cycles.
There is increased bone density and less risk of rheumatoid arthritis.
It is an extremely effective method of birth control that should not be denied simply because of age.
“Morning-after pill” . Minipills may be given to women who have relative contraindications to the combination pills. It must be taken every day at the same time. If a pill is missed, a backup method must be used.
Postpartum and breast-feeding women also need effective protection.
Combination pills can be started after 3 weeks if postpartum and not breast-feeding.
A patient exclusively breast-feeding may start the minipill 6 weeks postpartum.
Combination pills are not recommended in women who are breast-feeding because estrogen can decrease the amount and quality of breast milk.
II. Injectable combination contraceptive :

A. Lunelle, a combination of medroxyprogesterone acetate and estradiol cypionate, has received Food and Drug Administration (FDA) approval as a monthly injectable contraceptive. In comparison to the oral combination pill, contraceptive effectiveness is very high since the problem of forgetting pills is eliminated. In an initial study over the course of 1 year, there were no pregnancies in 782 women.
B. Side effects
are expected to be similar to that of the OCP. There seems to be higher rates of irregular bleeding during the initial months of use when compared with corresponding rates in OCP users.
C. return to fertility
Compared with long-acting progestins, return to fertility after discontinuation of this method is more rapid. Ovulation can occur as early as 6 weeks after the last injection. For this reason it is also important to receive follow-up injections within 5 days of the prescribed 28-day injection schedule.
III. Long-acting progestin contraceptives :
Since 1992, long-acting injectable forms of progestins have been approved in the United States. Medroxyprogesterone acetate (Depo-Provera) has been used around the world for more than a decade. Levonorgestrel implants (Norplant system), silastic capsules that release progestin for up to 5 years, were approved in 1990. The mechanisms of action for these forms of progestin are the same as with the combined pill and the minipill. Progestin interferes with endometrial growth, cervical mucus production, and possibly fallopian tube transport. It may suppress LH surge and prevent ovulation but this is not consistent. About one third to one half of cycles are ovulatory. Effectiveness has been shown to be excellent, exceeding even that of sterilization in one large study.
A. Types of progestins
Norplant system is six silastic subdermal capsules that contain levonorgestrel.
Each capsule is 34 mm long and 2.4 mm in diameter. The levonorgestrel is very stable and is released over a period of 5 years. During the first year, 80 µg/day is released, which is comparable with the minipill and is about 50% of the progestin in the combined pills. Gradually, the release decreases to 30 to 40 µg/day. At 5 years, the amount released is not enough to provide adequate protection.
Very obese women may have relatively lower serum levels and, therefore, less contraceptive efficacy.
A modification of the Norplant system (Norplant II) has only two subdermal capsules. Implanon has only one subdermal capsule .
Depo-Provera is the depot form of medroxyprogesterone acetate. It is given as an injection of 150 mg every 3 months. The contraceptive effects may last up to 4 months.
B. Failure rate
The failure rates for either method are extremely low, from 0.2% to 0.3% in the first year. Most of the “failures” were in women who were pregnant at the time of insertion or injection. The Norplant failure rate increases with time until at 5 years it is as high as1.1%.
C. Contraindications and risk factors
are fewer than with the combined pills.
These methods may be safely used in women who may have contraindications to the combined pills (i.e., estrogen).
Theoretically, there are concerns with progestins' effects on lipid levels. However, studies do not show a significant change in lipids or carbohydrate metabolism.
D. Evaluation and counseling considerations.
Long-acting progestins have noncontraceptive benefits similar to those of the pill , except that there is no protection from ovarian cysts. In fact, ovarian cysts can occur more frequently.
E. Complications and side effects
Early animal research with Depo-Provera suggested increased breast tumors in beagle dogs. Worldwide use and many years of follow-up have alleviated fears of this severe complication. A multinational study showed a slightly increased risk ratio of 1.2 in women younger than 35 only in the first 4 years of use. Risks were not increased in women who had used this method longer than 5 years.
Serious side effects are rare. However, many side effects are such nuisances that patients discontinue use.
The most common side effect is irregular bleeding from the lack of estrogen's stabilizing influence on the endometrium.
Bleeding patterns are unpredictable.
Amenorrhea can occur.
Other side effects include:
Headaches.
Nausea.
Weight gain.
Acne.
Ovarian cysts.
Hyperpigmentation over the Norplant site.
Depression, which can be severe, more so with Depo-Provera than with Norplant implants.
Other considerations.
This method does not interrupt sex for contraception.
It provides no protection against STDs, HIV, or hepatitis B transmission.
Long-acting progestins are not as accessible as other methods. Norplant requires an appointment to have it inserted and removed.
In some cases it is costly because it involves a procedure charge.
Depo-Provera must be given every 3 months so patients must remember (or be reminded) to return regularly for injections.
There are no long-term effects on fertility. Most women ovulate in the first month after discontinuing this method. However, medium-range delays in ovulation (up to 9 months) can occur with Depo-Provera.
F. Instructions
Clinicians should discuss all of the foregoing considerations with the patient .
Some practitioners recommend a trial of a minipill before committing to the injection or Norplant system.
It is ideal to begin the progestin within the first 7 days of menses.
A pregnancy test is recommended before administering the first dose of Depo-Provera or inserting the Norplant.
The Norplant insertion procedure is not difficult and takes about 15 to 20 minutes. Wyeth-Ayerst can be contacted for training materials.
Removal of Norplant can take longer and may be complicated by an initial irregular placement or by a fracture of the silastic capsule.
Patients should be aware of possible side effects and may want to keep track of bleeding.
Patients should call in with any change in the bleeding pattern since a pregnancy test may be indicated.
G. Clinical dilemmas
If spotting or irregular bleeding continues, the patient may be treated with
Ibuprofen (Motrin), 800 mg PO tid for 5 days.
Conjugated estrogens, 1.25 mg PO or estradiol, 1 mg PO every day for 7 days.
Ethinyl estradiol, 20 µg PO every day for 25 days.
Methyltestosterone with conjugated estrogens (Premarin), 2.5 mg every day for 25 days.
Some clinicians use low-dose birth control pills such as ethinyl estradiol-norethindrone (Ovcon 35) for one cycle.
If all of the foregoing methods fail and the woman wishes to continue treatment, then a hysteroscopy and a D & C can be done to rule out intrauterine pathology.
A barrier method should be used with any estrogen-only method of treatment as it may decrease the effectiveness of the progestins by thinning cervical mucus.
If a patient develops amenorrhea, a pregnancy test should be obtained. The patient can be reassured that the method is still effective even without a period.
It is important to remember that many patients still ovulate while taking progestins. If there is any change in a regular pattern of bleeding, a pregnancy test is advised.
Headaches, severe acne, and depression may be indications for discontinuing this method.
H. Special considerations
Both Depo-Provera and Norplant may be used by lactating women.
Adolescents and women older than 35 may be well suited to one of these methods for the same reasons as those discussed for the combined pills .
Mentally disabled patients may particularly benefit from this method.
IV. IUDs :
have been used since the beginning of the twentieth century. This is a popular method of birth control worldwide but less so in the United States. With proper patient selection and counseling, products could be used more often. IUDs are believed to inhibit pregnancy by producing a local inflammatory response in the endometrium. This hostile environment is thought to be spermicidal and there is theoretical evidence that tubal motility is affected. It is important to realize that IUDs are thought to be contraceptive not abortifacient. Failure rates of any IUDs are low. The Progestasert fails between 2% and 3% of the time, whereas the failure rate for the CuT 380A is between 0.5% and 0.8%.
A. Types of IUDs
Nonmedicated IUDs are no longer available in the United States but some women still have them. Among the more common types are the Lippes Loop and the Saf-T-Coil. These types of IUDs work indefinitely and there is no need to remove and replace them.
Copper T-380A (ParaGard) is a copper-containing device in a T-shape, 36 mm long by 32 mm wide. It is currently approved for up to 10 years of use.
Progestasert contains progesterone that is released locally, has progestin (atrophic) effects on the endometrium, and affects the cervical mucus. This particular progestin IUD must be replaced every year.
Mirena is a new levonorgestrel-releasing IUD that has received FDA approval. This IUD can be used for up to 5 years.
B. Contraindications and risk factors
PID and pregnancy are absolute contraindications for use of an IUD.
The risk of developing PID for the first time while using an IUD is dependent on the sexual activity of the woman and her partner.
A woman in a mutually monogamous relationship will have little increased risk of developing PID while using the IUD.
A previous ectopic pregnancy is no longer considered an absolute contraindication.
The newer copper IUDs protect against ectopic as well as intrauterine pregnancy.
The Progestasert offers less protection against ectopic pregnancy.
Experimental levonorgestrel IUDs offer good protection against ectopic pregnancies, probably by interfering with ovulation..
C. Counseling considerations
The manufacturers of IUDs have developed extensive consent forms that the provider should review with the patient.
The best candidate for an IUD is a multiparous (proven fertility) woman involved in a mutually monogamous relationship.
As with the pill, it must be stressed that this method provides no protection against STDs, HIV, or hepatitis B transmission.
Wearing an IUD and contracting an STD can lead to severe PID and possibly abscesses.
Selecting the type of IUD. Most patients will prefer to have the longer lasting CuT 380A (ParaGard).
Progestasert may decrease the severity of dysmenorrhea and anemia in some women.
Mirena has the same benefits as Progestasert, with the additional advantage of needing replacement only once in 5 years instead of yearly.
Risks at the time of insertion include perforation and infection. There is about a 5% expulsion rate.
Patients should expect some cramping and discomfort for a few months.
There can also be heavy menses, spotting, or an increase in vaginal discharge.
These symptoms can be treated with standard doses of nonsteroidal antiinflammatory drugs.
Approximately 10% of patients will discontinue this method because of these problems.
Return of fertility is as rapid as with barrier methods. The endometrial cavity returns to normal almost immediately after removing the IUD.
D. Instructions
Clinicians should be well skilled in how to insert the different types of IUDs.
It is best to insert the IUD during menses or just after an abortion. This is not a strict rule as long as pregnancy has been completely ruled out.
If there is a suspicion of STDs, cultures need to be taken and results obtained prior to inserting the IUD.
Perform a bimanual examination to determine size and position of the uterus.
Grasp the anterior lip of the cervix with a tenaculum and sound the uterus slowly and gently.
Load the IUD into the inserter barrel and with slow steady traction on the tenaculum slide the IUD inserter barrel into the uterus.
Gently remove the inserter, being careful not to tug the IUD string.
Clip the strings about 3 to 5 cm from the os. Leaving them longer initially allows for some retraction over the next several days as the IUD becomes seated within the uterine cavity. If the strings are cut too short, the partner may feel them.
Paracervical injection of 10 to 20 mL of 0.5% lidocaine provides an effective anesthetic block for difficult or painful insertion. However, a paracervical block is usually not needed for insertion.
Since the risk of perforation is greatest at the time of insertion, patients should return in 2 to 3 weeks to have the placement checked and to rule out expulsion or perforation. At this return visit, preferably after a menses, the string length can be cut shorter if needed.
Patients. Be sure each patient knows how to check for her IUD strings and does so regularly. If the strings are absent or if a period is missed, the patient should contact the clinician.
A second method of birth control is recommended during the first 3 months after insertion.
Each user should know what type of IUD she has and when her IUD should be replaced.
Most important, she should memorize the IUD danger signs. The first letter of each sign spells the acronym PAINS.
Period late or missing.
Abdominal pain.
Increased temperature.
Noticeable discharge.
Spotting.
E. Sequelae
Potential IUD complications are listed in order of decreasing severity.
Infection is the cause of most IUD-associated hospitalizations and deaths. IUD users are two to eight times more likely to require hospitalization for PID than women using no contraception. Infection rates are highest among women at high risk for PID, including young women with multiple sexual partners in areas where STD rates are high.
IUD infection can occur without any obvious sign of systemic sepsis and without fever. Symptoms, such as abnormal discharge, bleeding, or pelvic pain, should be treated as infection until proven otherwise.
Because fertility impairment can be a consequence, IUD infection warrants immediate aggressive management.
Uterine perforation, embedment, or cervical perforation can occur silently (with no symptoms) and may be discovered when IUD removal is attempted or when unintended pregnancy occurs. Symptoms may include pain, bleeding, and disappearance of IUD strings.
Ultrasound is often helpful in determining the location of an IUD but may not be accurate for a woman with large fibroids.
Cervical perforation may occur as an IUD is being expelled.
The Dalkon Shield is not visible on x-ray films. Although it has been off the market since the 1980s, a few women may still have it.
Pregnancy. Whenever pregnancy occurs in an IUD user, the probability of ectopic pregnancy must be carefully evaluated. Although IUD use does not cause ectopic pregnancy, the IUD's effectiveness in preventing conception with ectopic implantation is lower than its effectiveness in preventing intrauterine pregnancy.
If pregnancy occurs, the IUD should be removed when the string is still visible.
If the string is not visible, patients should be counseled that there is a 50% spontaneous abortion rate and elective termination may be offered.
Ectopic pregnancy should always be considered and ruled out by ultrasound or D & C, if appropriate.
Lost IUD strings are a common complaint. In most cases the string may be seen inside the cervical canal. Narrow forceps can be used to probe the cervical canal in an attempt to bring the strings into view.
Consider pregnancy if the strings are not visible on careful examination. If pregnancy is ruled out, then a search must be made for the IUD.
Ultrasound will be able to determine if it is inside the cavity or if it has eroded into the myometrium.
IUDs that are totally inside the cavity may be left in place.
In many places worldwide, IUDs are routinely placed without strings.
If ultrasound is unable to identify the IUD, a three-way x-ray of the abdomen should be obtained to ensure that it is not floating in the abdominal cavity.
If the IUD is in the abdominal cavity, the patient should be referred for laparoscopic removal.
If the IUD is not seen on x-ray examination, most likely it was expelled without the patient's awareness. Remember that the Dalkon Shield is not visible on x-ray films.
Spotting and bleeding may vary depending on the type of IUD. Unusual spotting or cramping may represent pregnancy or mild infection and should always be considered prior to any treatment.
The progestin-type IUDs generally lead to hypomenorrhea, but long-time use can cause atrophy and irregular spotting.
Copper IUDs are more likely to cause irregular spotting and cramping than are progestin-containing ones. Nonsteroidal antiinflammatory drugs can decrease these problems:
Difficult removal of an IUD. Removal of the IUD during menses is generally easy. An IUD should be removed with gentle traction on the string.
In older IUDs, the string may pull off or the IUD may not move from its position, indicating that it may be partially embedded.
A narrow packing forceps may be used to grab the end of the IUD.
Sometimes, a paracervical block and cervical dilation may be necessary.
If this is unsuccessful, an IUD hook may be used inside the cavity.
A “Novak” curette, used for endometrial biopsies, is useful because of the serrations at the end of the curette.
The patient should be referred for hysteroscopic removal when other methods have failed.
IUD expulsion. Between 5% and 20% of users expel the IUD within the first year of use.
Expulsion or partial expulsion is often entirely asymptomatic. Symptoms may include the following:
Unusual vaginal discharge.
Cramping or pain.
Spotting.
Dyspareunia.
Lengthening of the IUD strings.
Feeling the plastic of the IUD.
Noting the passage of the IUD from the vagina.
Replacement of an IUD can be done in one office visit. Preprocedural antibiotic coverage, such as doxycycline 200 mg PO, may be used. Although a recent study showed no benefit to the use of prophylactic antibiotics in reducing pelvic infection rates in new IUD placements (18).
Cramping and pain should not be accepted as normal consequences of IUD use. The possibility of ectopic pregnancy or infection must be carefully evaluated. Increased menstrual cramping or intermittent cramping can occur, especially with larger IUDs.
F. Special considerations
Postcoital contraception. Insertion of a copper IUD within 5 days after unprotected intercourse provides effective postcoital contraception. This approach to morning-after treatment is logical only for women who wish to continue using the IUD as a method of contraception and who have no contraindications.
It is contraindicated in nulliparas, adolescents, and rape victims.
All of the previously discussed contraindications and risk factors must be considered .
Effectiveness has been reported to be >99%.
Newer, very effective, hormonal methods of postcoital or emergency contraception (EC) have been approved for safe and effective use by the FDA. These approaches make IUD insertion for this indication less attractive.
The IUD may be an ideal method for the perimenopausal patient who has completed her family and does not want to risk another pregnancy.
G. Clinical dilemmas
Most of the problems arising with an IUD in place can be mimicked by pregnancy. Therefore, always consider pregnancy.
Infection, especially PID, can occur in users of IUDs and may develop serious sequelae.
Be sure that the patient does not have an ectopic pregnancy.
Any patient with a suspicion of PID should be treated immediately and probably hospitalized.
Frank PID must treated with antibiotics.
After the first dose is given, the IUD should then be removed.
An ultrasound should be obtained, if an abscess cannot be ruled out on clinical examination.
If the infection seems to be limited to the cervix (i.e., cervicitis, asymptomatic positive Chlamydia or gonorrhea culture), it can be treated without removing the IUD and with very close follow-up.
Following an episode of PID, a woman should wait at least 3 months (preferably 1 year) for insertion of another IUD.
If future fertility is a goal, then should be avoided.
Uterine or cervical perforation.
When partial cervical perforation occurs, the IUD can usually be removed by using alligator forceps to push the device back into the uterine cavity and then removing the IUD by grasping it with forceps or pulling gently on the string.
In a nonpregnant woman, an IUD located outside the uterus (intraperitoneal) usually can be removed through a laparoscope.
Management of pregnancy. Obtain a serum pregnancy test to exclude ectopic or intrauterine pregnancy for any IUD user who has missed one or more periods. If pregnancy is intrauterine, the IUD should be removed because of the high risk (50%) of spontaneous abortion and, often, of associated infections. IUD removal reduces but does not eliminate the possibility of miscarriage.
If the strings cannot be seen or located in the cervical os, IUD removal cannot be attempted and therapeutic abortion should be considered.
If a woman decides to continue a pregnancy with an IUD in place, she should be warned about the 50% risk of spontaneous abortion and should be educated about signs of infection.
Ectopic pregnancy should always be considered and ruled out by ultrasound or D & C, if appropriate.
Most of the IUD-associated deaths have been the result of rapidly progressive infection with incomplete spontaneous abortion.
Management of lengthening string.
When an IUD is partially expelled, in many cases the string descends through the cervix and appears longer. The possibility of expulsion must be excluded before other causes are considered. Pelvic sonography and examination of the endocervical canal with a sterile swab can assist in this determination.
The string can also lengthen if, after insertion, part of the string remained in the uterine cavity and the clinician cut the string based on the segment visible in the canal.
Indications for IUD removal.
Pregnancy, pelvic infection, and partial expulsion are indications for immediate IUD removal.
Removal is also indicated when persistent pain is a problem, excessive bleeding causes a drop of 5% or more in hematocrit, or the patient requests removal.
An IUD can be removed at any time in the menstrual cycle. If the patient has had midcycle intercourse and the IUD is removed immediately thereafter, there may be some reduction in IUD efficacy for that cycle.
V. Barrier methods :
Although possibly more cumbersome than the methods already discussed, barrier methods, specifically condoms, have assumed new importance in this age of the potentially life-threatening STD—HIV—as well as other problematic STDs such as hepatitis B, HPV (human papillomavirus), HSV (herpes simplex virus), Chlamydia, and gonorrhea. It is important to explain to sexually active couples that prevention does require different or supplementary measures in conjunction with pregnancy prevention.
A. Diaphragm
The diaphragm acts as a barrier and serves as a receptacle to hold spermicide against the cervical os. Diaphragms are ineffective unless used with spermicide. Failure rates are related to the motivation of the patient and range from 6% to 18%. There are several types of diaphragms and familiarity with them will help the practitioner recommend the appropriate one to the patient.
Types of diaphragms. Each diaphragm is available in size increments of 5 mm.
Arcing-spring rim. This diaphragm provides the sturdiest of spring strengths; the rim arcs can be folded, thus facilitating insertion for some women. Available sizes range from 55 to 95 mm.
Two arcing-spring products, Koro-Flex and Bendex, fold at only two points along the rim.
The Ortho product, All-Flex, folds at any point, although it is less sturdy than the other two.
Flat-spring rim. This diaphragm has a thin rim, with gentle spring strength. The rim folds flat for insertion and is available in sizes 55 to 95. It is slightly harder than others to place correctly, but comfortable once placed behind the pubic bone.
Coil-spring rim. The coil-spring diaphragm has firm spring strength and is available in sizes 50 to 95. It folds flat for insertion and can also be used with an introducer.
Wide-seal rim. This diaphragm has an arcing-spring or a coil-spring rim with an additional soft flange along the inner edge to create a seal with the vaginal mucosa. It is available through Milex Products in sizes 65 to 85.
Contraindications and risk factors include the following:
Allergy to latex or spermicide.
Recurrent urinary tract infection.
Introital or pelvic pain.
Active lesions that interfere with comfortable fitting or insertion.
History of toxic shock syndrome (TSS) or colonization with Staphylococcus aureus.
Lack of medical staff to fit and instruct adequately on diaphragm use.
Inability of the patient to master correct insertion or removal.
Anatomic abnormalities. Diminished vaginal muscle tone, previous obstetric laceration, uterine prolapse, cystocele, rectocele, extreme and fixed retroversion, vaginal fistula, and vaginal septum may make diaphragm fitting or use impossible.
Fitting may not be accurate for a woman who has had a full-term delivery in the past 6 weeks.
How to determine correct size and fit. Select the largest rim size that is comfortable for the user. Since vaginal depth increases during sexual arousal, a diaphragm that is too small may slip out of place. On the other hand, a diaphragm that is too large may cause discomfort or recurrent urinary infection.
The anterior rim should tuck just behind the symphysis pubis and the posterior portion of the rim resides snugly in the posterior vaginal fornix.
The diaphragms or rings used for fitting should be washed with soap and water and then immersed in a 70% alcohol solution for 20 minutes after each use.
Many clinicians rely primarily on the arcing-spring diaphragm since it fits most women and is easy to insert. The arcing-spring diaphragm is also useful for a woman with a long and firm cervix.
The coil-spring or flat-spring diaphragm may provide a comfortable fit for a woman who has firm vaginal tone, who finds the arcing spring uncomfortable, or who has had problems with recurrent urinary infections.
Instructions.
Clinicians.
Be sure each user is able to insert and remove her diaphragm and can verify correct position by palpating her cervix.
Have her practice placement and removal while in the office.
Ensure that she is comfortable with the method and answer any questions.
The importance of spermicide and consistent use should be stressed. Spermicide must be used with initial coitus and replenished with subsequent acts without removal of the diaphragm.
Each patient should also be aware that TSS could occur with diaphragm use if not removed within 24 hours.
Patients.
Apply 1 tablespoon of spermicide cream or gel to the inner dome of the diaphragm and along the rim.
If the diaphragm is placed in the vagina more than 6 hours before intercourse, another applicator full of spermicide should be inserted.
Insert the diaphragm by pushing the rim downward and toward the back wall of the vagina. The rim should fit just behind the pubic bone and should reach back behind the cervix.
Always check to make certain the diaphragm is covering the cervix.
Leave the diaphragm in place for at least 6 hours after intercourse. If you have intercourse again during the 6-hour time, insert an applicator full of spermicide, but do not remove the diaphragm.
Remove the diaphragm any time after 6 hours, wash it with soap and water, and let it dry. It can then be reinserted with new spermicide or stored in its case until again needed.
Avoid leaving the diaphragm in place any longer than 24 hours, but do keep to the 6-hour minimum time.
Do not use talcum or perfumed powder or any petroleum products (e.g., Vaseline) on your diaphragm.
If you experience danger signs of possible TSS while using the diaphragm, contact your clinician immediately. The danger signs are:
Fever of 100°F or more.
Diarrhea and vomiting.
Muscle aches.
Rash (like sunburn).
Diaphragm size should be reassessed after childbirth, or when approximately 10% of body weight is gained or lost.
Sequelae.
Side effects. Overall, the diaphragm is a very safe method of contraception.
TSS is the most serious potential problem, but is very rare. A handful of TSS cases, however, have been reported in association with prolonged diaphragm placement. These cases did not arise during menses as is more typical for TSS. Any patient who experiences TSS danger signs must be evaluated promptly, which includes diaphragm removal, vaginal culture for S. aureus, and prompt antibiotic treatment when indicated.
Other problems that can occur with diaphragm use include
See section on spermicides discussed in C, below.
Recurrent cystitis.
The size of the diaphragm should be checked.
If size is not the problem, the patient should be counseled to void prior to and after intercourse.
In some cases an antibiotic may be given prophylactically [i.e., nitrofurantoin (Macrodantin), 50 mg PO, or sulfamethoxazole-trimethoprim (Bactrim or Septra), PO after coitus].
Allergic reactions to latex or spermicide. If the reaction is to the spermicide, try different brands. It may, in fact, be a reaction to perfume or other additives.
Irritation from spermicide.
Foul-smelling vaginal discharge when a diaphragm is left in place too long.
Recurrent candidiasis if the diaphragm is not thoroughly cleaned out and dried after use.
Pelvic discomfort from rim pressure.
Patient or partner discomfort. There are many ways this may manifest itself. There has to be a level of comfort in the relationship to incorporate the use of barrier methods. Furthermore, some patients may have physical discomfort with the diaphragm. If it is too small, the partner may notice it as well as it will move around in the vagina during coitus.
Noncontraceptive benefits. Use of a diaphragm and spermicide may provide significant protection against STDs. Their use is associated with a decreased risk of developing cervical dysplasia.
B. Cervical cap
The soft, thimble-shaped cup fits over the cervix and is held in place by suction. Pregnancy is prevented through the cap's action as a barrier over the cervix and by its ability to hold spermicide in place. The reported failure rate is similar to that of the diaphragm. Manufactured and long used in England, the Prentif cap was approved by the FDA for use in the United States in 1988.
The cervical cap has a deep dome with a groove inside the firm rim to aid suction and it is available in four sizes, ranging from 22- to 31-mm internal rim diameter.
Contraindications and risk factors are the same as for the diaphragm, with the following exceptions:
Cap use is contraindicated for a woman who has Pap smear evidence of HPV infection, cervical intraepithelial neoplasia, or cervical dysplasia.
Cap use should not be initiated if the woman has acute PID, acute cervicitis, or vaginal infection or has undergone cervical biopsy or cryosurgery within the past 6 to 12 weeks.
The cap should not be used during the first 6 weeks after full-term delivery, when vaginal bleeding is occurring after spontaneous or induced abortion, or during normal menses.
How to determine correct size and fit. Because of variations in normal anatomy and the limited number of cap sizes available, it is not possible to fit every patient satisfactorily. Only about 50% of women can use this method successfully.
The cap must fit snugly over the cervix and remains by suction.
The cap dome should be deep enough so that it does not rest on the cervical os.
The cap should not be easily dislodged with a fingertip.
The cap user should check carefully for cap dislodgment after intercourse.
Instructions are the same as for the diaphragm, with the following exceptions:
Spermicide is not necessary. If used, it should fill the dome of the cap one third full. Using spermicide may prolong the wearing time.
The cap should be left in place at least 6 hours after intercourse but can be in for up to 36 hours.
Sequelae.
Little is documented concerning possible side effects or complications of the cervical cap.
Reports have noted vaginal lacerations and abrasions caused by the Vimule cap (not currently available in the United States) and abnormal thickening of the vaginal mucosa, possibly a reaction to chronic irritation (2).
Other researchers have expressed concerns about pelvic infection, acute cervicitis, and abnormal Pap smears possibly linked to cap use.
Failures occur when the cap is dislodged during intercourse.
Any noncontraceptive benefits are likely to be similar to those afforded by diaphragm use .
C. Spermicides and the contraceptive sponge.
Spermicidal contraceptives consist of two components: an inert substance, such as foam, gel, cream, or in the case of the sponge (currently unavailable), polyurethane; and a spermicidal agent (non-oxynol 9). Spermicides immobilize and kill sperm. In addition, the sponge provides a barrier between the sperm and the cervical os and traps the sperm within the sponge. The typical failure rates are 21% to 28%.
Although contraceptive sponges have been discontinued, they may again become available. Spermicidal agents are often used in combination with condoms to provide an extremely effective method of contraception, with a failure rate possibly lower than 1:100 woman-years. In the United States, the active spermicidal agent for products is non-oxynol 9. This is a surface-active substance that destroys cell membranes of sperm. Currently, controversy exists as to the practical effectiveness of non-oxynol 9 in destroying many organisms that cause STDs. In the laboratory, the chemical is lethal to organisms that cause gonorrhea, genital herpes, syphilis, trichomonas, and HIV. However, the evidence that non-oxynol 9 decreases STD risks (including HIV) in human studies has been mixed. There is even some concern that frequent non-oxynol 9 use can irritate the mucosa of the vagina and skin of the vulva, possibly increasing susceptibility to HIV. Also, cystitis (discussed later) may be increased by non-oxynol 9 use, which allows for intravaginal proliferation of Eschericia coli, which is a frequent cause of cystitis .
Type of spermicidal method. All methods are available without prescription.
Foam. Used alone, there is a wide disparity between perfect-use effectiveness and actual-use effectiveness. Common mistakes include inconsistent or careless use, using too little foam, failing to shake the container vigorously enough, not placing the foam high enough in the vagina, and douching too soon after intercourse.
Cream and gel. When used alone, these are slightly less effective than other spermicides. Cream products have better dispersion to cover the cervix and vagina than do gels. Cream and gel are often used in conjunction with the diaphragm or cervical cap.
Suppositories and tablets dissolve over a period of 10 to 30 minutes after placement in the vagina but retain their full effectiveness for less than 1 hour. Mistakes arise from not allowing the tablet or suppository to dissolve, failing to remove the wrapper, placing the spermicide incorrectly, or having intercourse after the fully effective interval.
Contraceptive sponge. In the future, this method may again become available. The polyurethane sponge incorporates 1 g of nonoxynol-9. Approximately 200 mg of spermicide is released during the initial 24 hours of use. It has a concave dimple on one side that fits over the cervix and a woven loop to facilitate removal.
Contraindications and risk factors.
Contraindications to spermicide use include allergy to the active ingredient or base or physical inability to insert or use the product correctly.
Additional contraindications specific to sponge use include:
Anatomic abnormalities such as uterine prolapse, rectocele, cystocele, extreme uterine retroflexion, or vaginal septum when they interfere with placement or retention of the sponge.
History of TSS or vaginal colonization with S. aureus.
Prevention against STDs, HIV, and hepatitis B transmission is less ensured when these methods are used alone.
Instructions. Different formulations of spermicides have different effective times. Most must be placed within 1 hour of intercourse. The length of time protection lasts varies from 1 to 8 hours.
Correct use of a spermicide entails following package instructions carefully:
Removing the wrapper from tablets or suppositories.
Filling the applicator completely with foam, cream, or gel.
Placing the spermicide as close to the cervix as possible.
Applying additional spermicide for each act of intercourse.
Inserting the spermicide before intercourse.
Not douching for at least 6 hours after intercourse.
The sponge.
Correct use requires moistening the sponge with clean water, placing it over the cervix, and leaving it in place for at least 8 hours after intercourse.
The sponge should not be worn for longer than 24 hours.
Each user should learn the danger signs of TSS and know how to contact her clinician if these signs occur. TSS symptoms include high fever, rash, diarrhea, vomiting, and muscle aches.
Sequelae.
Spermicides.
Possible complications of spermicide use include irritation, allergic reaction, and failure of suppository or tablet to melt or foam.
Noncontraceptive benefits include decreased incidence of gonorrhea and trichomoniasis, augmented vaginal lubrication, and possibly some protection against cervical neoplasia.
Contraceptive sponge.
Sponge use involves the possible complications of spermicide .
Some users also experience dryness of the vagina and difficulty with removal or tearing of the sponge.
It is not known whether or not sponge use increases the risk of TSS.
Noncontraceptive benefits of the sponge include those listed for spermicides as well as absorption of vaginal secretions and ejaculate.
Clinical dilemma. When spermicide users experience an allergic reaction, the offending agent is often the perfume or base, although it may be the active spermicidal ingredient. Recommend a nonperfumed spermicide. Check the ingredients of the problem product and consider recommending one containing different ingredients.
D. Condoms
Mechanical barriers to cover the penis during intercourse have been used for hundreds of years. Synthetic condoms were developed after 1840. The popularity of condoms has made this the third most commonly used contraceptive method in the United States. Reported failure rates range from 2 to 12 pregnancies per 100 woman-years.
Types of condoms.
Most condoms are made of latex. About 1% are made from lamb cecum (“natural” skin condoms). Newer polyurethane (plastic) condoms are available and are also useful for those with latex allergy.
Condoms are available lubricated or nonlubricated, straight or tapered, and with or without reservoir tip. Some condoms have external ribbing.
Latex and plastic condoms can prevent transmission of all STDs, including the viral ones (HIV, HPV, HSV, hepatitis B), but natural or lambskin do not prevent transmission of viral STDs.
When protection against transmission of HIV is a consideration, latex condoms in conjunction with spermicide use are recommended. Skin condoms (natural) are more porous than latex, and small particles such as HIV may traverse the intact condom barrier.
Female condoms are available. These are pouches of plastic that line the vagina and cover the cervix.
Contraindications and risk factors.
Allergy to latex is a contraindication. Natural or plastic condoms can still be used.
Some men report difficulty maintaining an erection when using condoms, although others find that condom use is helpful for this.
Instructions. A new condom must be used for every act of intercourse and placed on the penis before any vaginal entry.
Patients should be instructed to place the condom on the erect penis before the penis touches the partner.
The end of the condom should extend beyond the tip of the penis and air should be removed to form a small receptacle.
Lubricants should be water-based only. Oil-based lubricants can weaken the condom.
After intercourse, the penis should be withdrawn while it is still erect, taking care to keep the bottom of the condom from coming off the base of the penis.
Jewelry, fingernails, and sex toys may tear the condom.
Average breaking rates for latex condoms are 1% to 2% and are greater for plastic, up to 7%. If breakage occurs, concomitant use of spermicides substantially decreases the risk of pregnancy.
Condoms should be stored in a cool, dry place and should not be reused.
Petroleum jelly can cause a condom to deteriorate.
Couples using condoms need to know about morning-after hormonal treatment.
Sequelae.
Complications.
The condom may reduce sensitivity of the glans penis. In some cases, use of the natural skin condoms may help.
Some users object to interruption in lovemaking to place the condom on the penis.
Very rarely, an allergic reaction to latex or lubricant can occur.
Noncontraceptive benefits. Condom use is one of the few opportunities for men to play an active role in contraception.
Condoms greatly reduce the transmission of STDs, hepatitis B, and HIV and diminish the likelihood of cervical cancer.
Condoms may also be of help in treatment of premature ejaculation and in preventing exposure to ejaculate for a woman who is allergic to her partner's semen or develops antibodies that cause infertility.
VI. Fertility awareness :
is also called natural family planning. The various methods include rhythm, basal body temperature (BBT), Billings (mucus) method, and the symptothermal methods. All these methods require periodic abstinence with unsafe days determined by physiologic changes that occur during a woman's menstrual cycle. Women who are well educated concerning their cyclic changes, have regular menses, are disciplined, and are willing to cope with possible pregnancy may have good success with fertility awareness. Some users choose to monitor several cyclic changes or combine fertility awareness with alternative contraceptive methods or both.
Failure rates range from 2% to 35%, depending on the method used and on whether alternative birth control was employed. Best success is reported for couples who abstain throughout the preovulatory phase and do not have intercourse until the fourth day after ovulation is clearly documented. Most failures occur because of intercourse during “early safe” days, when ovulation occurs a few days earlier than anticipated. Temperature and mucus changes do not predict ovulation accurately enough to avoid this problem.
VII. Sterilization :
is the most commonly used method of birth control in the United States. The pregnancy rates are 0.2 to 0.4 for tubal ligation and 0.15 for vasectomy per 100 woman-years. For the purpose of decision making about sterilization, these procedures should be considered irreversible.
A. Types of sterilization
Vasectomy.
This operation for men is a simple and safe procedure that prevents sperm passage by blocking the vas deferens. The clinician can ligate the vas deferens through a small incision of the scrotum.
Reversal is moderately successful. Depending on the type of vasectomy performed and the time interval to vasovasostomy, vasectomy reversal procedures can result in clinical success up to 50% of the time. Success diminishes if the vasectomy was performed over 10 years ago.
Tubal ligation. The fallopian tube can be blocked by ligation, coagulation, or mechanical occlusion with clips, bands, or rings. Tubal reanastomosis is generally less successful than is vasovasostomy and will be recommended only if a substantial portion of undamaged fallopian tube is available for repair. Reversal rates as high as 50%, however, have been reported for reanastomosis after clip ligation or surgical ligation with minimal damage. This rate is much lower when electrocautery has been used. The types of tubal ligation include the following:
Abdominal approach. More than 100 variations of abdominal tubal ligation have been developed. Two of the most commonly used methods are laparoscopy and minilaparotomy. Both procedures can be performed under local or general anesthesia.
For laparoscopy, one or two 1-in. incisions may be required, one for the laparoscope and one through which the tubes are grasped with forceps for coagulation or clip applications.
For minilaparotomy, a 2- to 3-cm incision approximately 3 cm above the symphysis pubis allows the surgeon to grasp the fallopian tube for ligation. Minilaparotomy is most feasible for patients with minimal abdominal wall fat.
Vaginal approach. The fallopian tubes can be approached by vaginal culdotomy or rarely by culdoscopy. Because of high complication rates, the advantages of an unobtrusive scar and rapid recovery are less attractive.
Hysterectomy. At one time, hysterectomy was the most common method of sterilization. This approach may be considered for women who are likely to require later hysterectomy because of known gynecologic disease but should not be a routine recommendation. Hysterectomy mortality is 10 to 100 times higher than that of tubal ligation, and the associated morbidity as well as cost in money and time is much greater.
B. Contraindications and risk factors
Ambivalence is a strict contraindication. Only a patient who wishes to terminate fertility should undergo sterilization. In reaching a decision, the possible impact of divorce or family tragedy should be considered. Remarriage is the most common reason cited for requesting reversal.
A patient who is obese, has cardiovascular disease, or has a serious medical condition that might increase anesthesia or surgery risks should be encouraged to consider alternative methods of fertility control.
C. Counseling
Every patient must understand that sterilization surgery is not 100% effective and that pregnancy can occur in rare cases. Because of the permanent and completely elective nature of sterilization surgery, informed choice and informed consent are crucial. The mnemonic BRAIDED has been developed for the essential components of informed consent counseling.
Benefits: It is effective and convenient.
Risk: Risk of method including consequences of method failure.
Alternatives: The patient must be informed about possible alternatives, including advantages and disadvantages of each.
Inquiries: Any questions the patient may have should be answered fully by the clinician.
Decision: The patient must feel free to decide against the proposed method, without implied pressure or coercion.
Explanation: The procedure planned must be explained in specific detail.
Documentation: Information provided to the patient should be entered in the medical record, along with a written consent form signed by the patient.
D. Sequelae
Male sterilization.
Vasectomy is a very safe procedure. Complications are generally minor and short term. Swelling, discoloration, and discomfort are common during the first few days after surgery.
More significant, but uncommon, complications are hematoma, granuloma, epididymitis, and wound infection.
One half to two thirds of men develop sperm antibodies after vasectomy, but the possible significance of this is unknown.
Approximately 0.4% of vasectomy procedures fail to terminate fertility. In most cases, failure is evident within a few weeks, as postoperative semen shows continuing sperm release.
Sperm counts should be obtained after 20 ejaculations and a repeat sperm count done at 2 months.
Approximately 10% will need to repeat the sperm count 1 to 2 months later to ensure that the count has decreased.
It is recommended that all men have a repeat sperm count 6 months after the vasectomy.
A backup method of contraception should be used until the semen no longer shows sperm release.
Female sterilization. Tubal ligation is also extremely safe. The greatest risk is in the type of anesthesia used with general anesthesia having the highest risk.
Complications of tubal ligation could involve damage to one or both ovaries or to the ovarian blood supply, and this could cause menstrual disturbance or a change in the hormonal milieu. Whether such problems can be linked to uncomplicated tubal ligation, however, has been an issue of controversy. Long-term follow-up in large case-control studies have found menstrual disturbances equally as frequent among controls as among sterilization cases.
Complications occur in fewer than 2% to 3% of women undergoing minilaparotomy and include infection, hematoma, uterine perforation, and bladder injury.
Complications are also rare with laparoscopy. The procedure can cause mesosalpingeal tear, bowel burn, uterine perforation, or hemorrhage.
Vaginal tubal ligation complication rates are approximately twice as high as those for laparoscopy or minilaparotomy, with infection and hemorrhage accounting for most of the problems.
Tubal ligation failure rates depend on the specific surgical method used.
Following laparoscopy, approximately 0.25% of patients experience failure. Ectopic pregnancy and pregnancy already established at the time of the surgery are the most common.
Postpartum tubal ligation, sterilization at the time of caesarean section delivery, and abdominal ligation by the Pomeroy method have somewhat higher failure rates.
VIII. Abortion :
Approximately 1.6 million abortions are performed annually in the United States; more than 90% are performed early in pregnancy using vacuum aspiration. Although the complication rate for abortion is as low as, or lower than, any other method of fertility control, very few women choose it as a primary fertility control method. Patient acceptance of effective contraception is extremely high at the time of unintended pregnancy, so birth control information and supplies are an important part of clinical management. Early identification and confirmation of pregnancy are also crucial tasks for all family-planning clinicians.
With the marked increase in ectopic pregnancy rate, early pregnancy identification can be lifesaving. Early confirmation also permits optimal initiation of prenatal precautions and care and early termination if abortion is the patient's decision. Abortion risks are lowest at approximately 7 to 8 weeks gestation and double for every 2-week delay thereafter. This method is not accepted in Islamic .
IX. Postcoital or EC :
has been mentioned in other sections. Practitioners need to be more aware of this option and feel comfortable using it. Patients need to be counseled that it is available as a backup if one of the foregoing methods is not used correctly (i.e., a failed condom). EC prevents ≈ 75% of expected pregnancies, probably closer to 95% when used within 24 hours of intercourse. In a recent review article about EC, Glasier thoroughly discusses the mode of action of these hormonal techniques and states, “The prevention of pregnancy before implantation is contraception and not abortion” . There is considerable current advocacy to make EC available without prescription in the United States. Evidence exists that this approach could reduce the unwanted pregnancy rate without risk to the users. There are two methods of postcoital contraception, hormonal and the IUD.
There are two main hormonal approaches to EC using either combination estrogen and progestin OCPs or progestin-only contraceptive pills. Together these are referred to as emergency contraceptive pills (ECPs). In 1997 the FDA declared the combination method of ECP use both safe and effective for use in pregnancy prevention. Previously studied, but not currently used, methods include danazol (an antigonadotropin) and high-dose estrogen-only regimens. It may be that antiprogesterone, mifepristone (RU-486), will be used for postcoital contraception. Effective contraception must be used within 72 hours of unprotected sex.
Combination estrogen and progestin methods include a large number of easily available formulations.
In all cases two doses are required, the first within 72 hours of intercourse, the second 12 hours after the first dose.
All use ethinyl estradiol 100 to 120 mcg and levonorgestrel 0.50 to 0.60 mg per dose. This is convenient because many conventional OCPs contain appropriate dosages of these hormones when taken in multiples.
For example, Ovral contains 50 mcg ethinyl estradiol and 0.25 mg levonorgestrel. Thus, taking two Ovral pills 12 hours apart provides the correct dose of ECPs.
Similarly, Lo/Ovral contains 30 mcg ethinyl estradiol and 0.15 mg levonorgestrel. Thus, four Lo/Ovral pills per each dose provides the correct dose.
One commercially available product, Preven, contains four tablets each containing 50 mcg of ethinyl estradiol and 0.25 mg levonorgestrel.
Progestin-only method. Currently, only one such method is commercially available; “Plan B,” which contains a single pill containing 0.75 mg of levonorgestrel, is taken within 72 hours of intercourse. This method was shown in a large multinational trial to be as effective as the combination estrogen and progestin regimen and may be preferred because of its low incidence of nausea and ease of single dosing.
The most common side effect of ECPs is nausea. Using combination pills, the incidence of nausea is 30% to 50% and approximately 20% have emesis. These rates drop by more than half with the progestin-only method. If vomiting does occur within 3 hours of either dose, some feel it should be repeated with an antiemetic.
Although the ECPs may slightly alter the expected menstrual interval, patients should expect to see their menses by 21 days after treatment. If the pregnancy ensues, the patient should be counseled appropriately concerning an undesired pregnancy. If she opts to continue the pregnancy, there is no evidence of teratogenic effects.
IUD placement within 5 days of conception can successfully prevent pregnancy with failure rates of less than 1%. .

SEXUALLY TRANSMITTED DISEASES , Dr. Alaa Mosbah MD OBS and GYN

Introduction :

Twenty or more infectious diseases may be transmitted by sexual contact. This chapter reviews those associated with cervicitis, gonorrhea and chlamydia, and those characterized by genital ulcers, syphilis, herpes, chancroid, lymphogranuloma venereum, and granuloma inguinale as well as the parasitic skin infestations, pediculosis pubis and scabies. Sexually transmitted diseases (STDs) often coexist. It is strongly recommended that whenever serologic testing is done, screening for syphilis (rapid plasma reagin test [RPR], HIV, hepatitis B surface antigen (HBsAg) and hepatitis C titer should be included routinely.

Classification:

BACTERIAL:

•Neisseria gonorrhea (gonorrhea)

Chlamydia trachomatis (Chlamydia)

•Treponema pallidum (Syphilis)

.Hemophilus ducreyi (Chancroid)

•Calymmatobacterium granulomatis (Donovanosis or granuloma inguinale)

•Gardnerella vaginalis (Bacterial vaginosis)

•Others: eg. Mycoplasma hominis , Ureaplasma urealyticum

VIRAL:

- Herpes simplex virus

- Human papilloma virus

- Hepatitis B virus

- HIV (AIDS)- Cytomegalovirus

- Molluscum contagiosum virus

PROTOZOAL: Trichomonas vaginalis (Trichomonal vaginitis)

ECTOPARASITES:

§Phthirius pubis (pubic lice infestation)

§Sarcoptes scabiei (scabies)

Consequences of STIs:

For women:

§Infertility

§Ectopic pregnancy

§Cervical cancer

§Adverse pregnancy outcomes ( prematurity, neonatal infection)

For children:

Eye infection

Blindness

For men :-Infertility

I. Gonorrhea.

Urogenital purulent inflammation is the most common form of infection with the gram-negative, intracellular diplococcus Neisseria gonorrhoeae, which has an avidity for columnar and transitional epithelium. Transmission is almost always by sexual contact, with a usual incubation period of 2 to 8 days. In the United States, an estimated 600,000 new infections are reported annually.

A. History.

The acute attack usually follows sexual exposure or a menstrual period. Symptoms include vaginal discharge, urinary frequency and dysuria, menstrual irregularity, and bilateral lower abdominal pain. An asymptomatic carrier state is common in both sexes. The incidence of asymptomatic gonorrhea in men has been estimated to be as low as 12% and as high as 50%. The estimated incidence for asymptomatic women ranges from 50% to 80%. Infections in other mucosal sites, such as the oropharynx and anorectal area, are usually asymptomatic, but may lead to complaints of pain and discharge. Hematogenous spread may occur, causing manifestations such as septic arthritis and skin lesions. The most common dissemination, however, is by mucosal passage to the fallopian tubes and ovaries, resulting in pelvic inflammatory disease (PID), occurring in 10% to 15% of infected women .

B. Physical examination.

In the asymptomatic case, the physical examination may be entirely normal. There may be a purulent discharge, or Skene's or Bartholin's glands may be inflamed. However, these are nonspecific signs, and the diagnosis is dependent on bacteriologic investigations. The classic presentation of acute gonococcal PID, with fever, abdominal and adnexal tenderness, and a purulent discharge, is often absent.

C. Investigative procedures

A Gram stain of urethral or cervical secretions is unreliable since there is a 60% to 70% false-negative rate in female patients.

Gonorrhea culture, on Thayer-Martin or equivalent medium. The culture should be placed in a candle jar since the organism is fastidious, requiring aerobic conditions with an increased carbon dioxide atmosphere to grow. Incubation should begin as early as possible. Depending on the history, cultures may also be required from the pharynx and rectum.

Enzyme immunoassay (ELISA), polymerase chain reaction (PCR), and ligase chain reaction (LCR) assays on endocervical or urine samples have largely replaced culture methods of diagnosis and are at least as accurate.

Serologic testing for syphilis should be done on all patients. HIV testing and screening for HBsAg and hepatitis C are strongly recommended.

Chlamydia testing should be done at the same time the gonorrhea culture is obtained.

D. Management.

Therapy is based on antibiotic sensitivity, site of infection, and concurrent STDs. Antibiotic resistance is mediated through two genetic mechanisms: chromosomal-mediated resistant N. gonorrhoeae and plasmid-mediated resistance. Two types of plasmids are important: one for penicillinase and one for high-level tetracycline resistance. Rectal infections are relatively refractory to amoxicillin and tetracycline, and pharyngeal infections to amoxicillin and spectinomycin. Chlamydia trachomatis is a common coinfective agent and should be covered with empiric therapy. A summary of the guidelines for treatment recommended by the Centers for Disease Control and Prevention (CDC), Atlanta, in 1998 follows.

Treatment of adults

Uncomplicated gonococcal infections are treated with empiric single-dose therapy consisting of ceftriaxone, 125 mg IM once. Mixing 1% lidocaine reduces the discomfort of the injection. Other recommended single-dose regimens include cefixime, 400 mg PO; or ciprofloxacin, 500 mg PO; or ofloxacin, 400 mg PO. Alternative regimens include spectinomycin, 2.0 g IM for patients who cannot tolerate cephalosporins or quinolones. Injectable cephalosporins that are also effective include ceftizoxime, 500 mg IM; cefotaxime, 500 mg IM; cefotetan, 1 g IM; and cefoxitin, 2 g IM. Oral cephalosporin regimens include cefuroxime axetil, 1 g PO; and cefpodoxime proxetil, 200 mg PO. These two regimens are less effective against pharyngeal infections. Other quinolone regimens include enoxacin, 400 mg PO; lomefloxacin, 400 mg PO; and norfloxacin, 800 mg PO. Many other antibiotics are effective, and this does not represent a comprehensive list of all suitable treatments.

All treatment regimens should include a single dose of azithromycin 1 g PO or a 7-day course of oral tetracycline or doxycycline to eradicate concurrent chlamydial infection, which has been documented in up to 45% of gonorrheal cases in some populations. These drugs are not considered adequate therapy for gonorrhea. Generic doxycycline costs a little more than tetracycline but provides the advantage of a 100-mg bid dosage unrelated to meals, compared with a 500-mg qid dosage between meals with tetracycline. The alternative regimen is erythromycin stearate, 500 mg; erythromycin ethylsuccinate, 800 mg; or erythromycin base, 500 mg PO qid for 7 days .

All patients should have a serologic test for syphilis and should be offered counseling and testing for HIV infection. Most patients with incubating syphilis (in who there is no clinical evidence and who are seronegative) may be cured by any of the foregoing regimens, with the exception of spectinomycin and the quinolones. Patients treated with these drugs should have a syphilis serologic workup in 1 month.

Pharyngeal infections should be treated with ceftriaxone, 125 mg IM. Those who cannot receive this drug should be treated with ciprofloxacin, 500 mg PO, as a single dose; and these patients require repeat culture 5 to 7 days later. Trimethoprim, 720 mg; sulfamethoxazole, 3600 mg PO once daily for 5 days may be an effective alternative therapy.

Sexual partners should be identified, examined, cultured, and treated presumptively.

Follow-up culture (so-called test of cure) following combined ceftriaxone-azithromycin or doxycycline therapy is not essential since treatment failure is rare. Reculture 1 to 2 months later (rescreening) detects both treatment failures and reinfections. Patients treated with other regimens and those with persistent symptoms should have cultures 4 to 7 days after completion of therapy.

Treatment failures after one of the recommended regimens are usually due to reinfection, indicating a need for improved contact tracing and patient education. Nevertheless, antibiotic sensitivities and chlamydial cultures are indicated. Additional treatment with ceftriaxone and azithromycin or doxycycline should be given.

Pregnant women should be treated with ceftriaxone, 125 mg IM, plus azithromycin 1 g PO or erythromycin base, 500 mg PO qid for 7 days. (Erythromycin stearate, 500 mg; erythromycin ethylsuccinate, 800 mg; or an equivalent may be substituted for erythromycin base). Tetracyclines (including doxycycline) and the quinolones are contraindicated in pregnancy because of possible adverse fetal effects. Pregnant women allergic to beta-lactams should be treated with spectinomycin, 2 g IM, followed by erythromycin. Test of cure is required for these cases.

Disseminated gonococcal infection (arthritis-dermatitis syndrome). The condition may be monoarticular or polyarticular. Skin lesions are commonly present with the arthritis. They begin as small red papules, evolving through vesicular and pustular stages to lesions with a necrotic center superimposed on a hemorrhagic base. Healing is usually spontaneous. Hospitalization is usually indicated, especially for those who cannot reliably comply with therapy or who have an uncertain diagnosis, purulent joint effusions, or other complications. Treatment schedules for this syndrome are included in the CDC guidelines but are outside the scope of this chapter.

Miscellaneous. The CDC guidelines also recommend schedules of therapy for infants born to mothers with gonococcal infections, for gonococcal ophthalmia in adults, and for neonatal infections. These are problems seldom encountered in a medical or gynecologic outpatient department. However, adolescents may be seen and should receive similar regimens. Children weighing more than 100 lb (45 kg) receive adult dosage while those weighing less receive dosages adjusted to weight. In all pediatric cases, the possibility of sexual abuse must be considered.

E. Sequelae.

The short-term and long-term complications and sequelae of gonococcal infections are mainly related to gonococcal PID .

II. Syphilis.

The infectious agent is a spirochete, Treponema pallidum. Spread is by sexual intercourse or by intrauterine transmission (congenital syphilis). The incubation period is usually 2 to 6 weeks, with a primary sore (chancre) appearing at the site of infection and remaining for 1 to 6 weeks. Manifestations of the secondary stage may appear 2 to 12 weeks later. During early latency (1–4 years), relapses with mucocutaneous lesions may occur. Thereafter, there are no relapses and the syphilis is noninfectious, except transplacentally. Late symptomatic syphilis is generally characterized by cardiovascular or neurologic disease, although any tissue can be involved.

The incidence of syphilis in the United States in 1995 was 9 cases per 100,000 population.

A. Early (primary, secondary, latent less than 1 year)

History. The primary chancre usually appears on the genitalia, mouth, or anus and is painless. The secondary stage may present with ulcerations of mucous membranes or skin eruptions. Frequently there is only a flulike syndrome with a fever, sore throat, and muscle pain. During the latent phase, the patient is generally asymptomatic. Nearly two thirds of patients pass through the primary and secondary stages without realizing it. The clinical spectrum of syphilis acquired in utero includes stillbirth, neonatal death, neonatal illness, and development of the stigmata of congenital syphilis in later life.

Physical examination. Chancres vary in appearance but the usual feature is that of a nontender clean-cut ulcer with an indurated base and an associated regional adenopathy. The secondary-stage skin lesions tend to be widespread and symmetric, with 60% to 80% of patients having lesions on their palms and soles. Cutaneous lesions tend to be maculopapular. Condylomata latum are intertriginous papules formed at areas of friction and moisture, such as the vulva. Mucosal or mucocutaneous lesions appear in 21% to 58% and include pharyngitis, tonsillitis, and the “mucous patch” (a papule with a central erosion found on the oral and genital mucosa). Lymphadenopathy is a very common finding in the secondary stage.

Investigative procedures. Dark-field microscopy of fluid expressed from lesions may demonstrate the organism. In practice, serologic tests are of major importance in diagnosis. Nontreponemal tests (Veneral Disease Research Laboratories test [VDRL] and RPR) are used for screening and may be repeated quantitatively as a guide to therapeutic response. The tests become positive 1 or 2 weeks after the appearance of the chancre. They are positive in approximately 66% of primary cases, in 99% of secondary cases, and in about 70% of late cases. These tests are nonspecific, with biologic false-positive results occurring in association with other infections and diseases (e.g., infectious mononucleosis, collagen vascular diseases). The titer is usually low (no more than 1:8), with a false-positive test. Treponemal tests (fluorescent treponemal antibody absorption test [FTA-ABS], Treponema pallidum immobilization test [TPI]) are specific, but are not quantitative, and remain positive even after adequate therapy. The treponemal tests, therefore, are used to confirm the diagnosis. The FTA-ABS test is positive in 85% of primary and 100% of secondary cases and may be the only positive test in tertiary cases. Positive serologic studies in the newborn may be passively acquired, but most physicians treat all VDRL-positive neonates. All patients with evidence of latent syphilis should have a lumbar puncture with a cerebrospinal fluid (CSF) VDRL to rule out neurosyphilis .

Management. The CDC recommendations (1998) are summarized as follows:

Drug therapy for early syphilis is benzathine penicillin G, 2.4 million units IM in a single dose. Penicillin-allergic patients should receive doxycycline, 100 mg PO bid; or tetracycline hydrochloride, 500 mg PO qid for 14 days. An alternative regimen is erythromycin, 500 mg PO qid for 14 days. Various ceftriaxone regimens may also be considered. Pregnant patients are treated similarly, but tetracyclines are contraindicated. Penicillin is the only acceptable therapy for the pregnant patient. Following documentation of penicillin allergy by skin testing, reactive patients should be desensitized and treated with penicillin. Desensitization should be performed in consultation with an expert and only where adequate emergency facilities are available.

Quantitative nontreponemal tests should be repeated at 3, 6, and 12 months after treatment. Pregnant women who are treated should have monthly tests until delivery.

Retreatment may be indicated if there is a fourfold increase in titer, an initial high titer fails to show a fourfold decrease within a year, or clinical signs persist or recur. Retreatment should consist of schedules recommended for late syphilis .Pregnant women who are treated and who do not show a fourfold decrease in titer in a 3-month period should be retreated.

Miscellaneous. Cases of syphilis should be reported within 48 hours of diagnosis to a local or state health department, which usually offers referral and follow-up services. Sexual partners are notified without identification of the index case.

Sequelae. One third of all untreated patients develop sequelae that are generally confined to the CNS and cardiovascular system.

B. Late (neurosyphilis, latent more than 1 year)

History, antecedent treatment, and previous serologic tests are important in establishing the diagnosis. Patients with latent symptomatic syphilis present with complaints relevant to the particular organs involved (see section II.B.2). The latent stage prior to clinical presentation ranges from 3 to 20 years.

Physical examination. The typical lesion of late syphilis is the gumma. These nodular ulcerative lesions can involve skin, mucous membranes, skeletal system, and viscera. Cardiovascular syphilis manifests with aortitis, aneurysm, or aortic regurgitation. Neurosyphilis may be asymptomatic or symptomatic, presenting as tabes dorsalis, meningovascular syphilis, or general paralysis of the insane. Iritis, choroidoretinitis, and leukoplakia may occur.

Investigative procedures. CSF VDRL should be done for clinical signs and symptoms consistent with a CNS lesion and for patients with syphilis of more than 1-year duration to exclude asymptomatic disease.

Management

Recommendations for therapy of cardiovascular, late benign syphilis, and syphilis of more than 1-year duration are as follows: benzathine penicillin G, 2.4 million units IM weekly for 3 weeks; or if penicillin-allergic, doxycycline, 100 mg PO bid, or tetracycline hydrochloride, 500 mg PO qid, for 30 days. Alternatively, if the patient is pregnant or unable to tolerate tetracyclines, desensitization in consultation with an expert may be indicated.

Neurosyphilis may be treated with aqueous crystalline penicillin G, 12 to 24 million units, administered as 2 to 4 million units q4h IV for 10 to 14 days. An alternative regimen is procaine penicillin, 2 to 4 million units IM daily, with probenecid, 500 mg PO qid, both for 10 to 14 days. After completion of these regimens, many authorities recommend the addition of benzathine penicillin G, 2.4 million units IM. Patients allergic to penicillin should be skin-tested and desensitized in consultation with an expert.

Up to 80% of patients treated during the late stages of syphilis remain seropositive indefinitely, although their titers should decrease over time.

The provider should keep in mind that the Jarisch–Herxheimer reaction can occur, producing fever, myalgia, tachycardia, and hypotension within 24 hours of treatment. Some authors recommend hospitalization of pregnant patients since this reaction places mother and fetus at increased risk.

III. C. trachomatis

is a bacterial intracellular parasite that causes a wide range of infections. In women, these include cervicitis, salpingitis, perihepatitis, and urethritis. There are 15 serotypes, and those associated with genital infection are D to K, whereas the L strains are associated with lymphogranuloma venereum. In the United States, approximately 4% to 5% of sexually active women carry Chlamydia in their cervix; and this site appears to play a central role in transmission, with the horizontal spread to male partners and the vertical spread to neonates. There are an estimated 4 million cases annually in the United States.

A. History.

Chlamydial cervicitis is frequently asymptomatic. However, a purulent discharge may be found. Dysuria and frequency (urethral syndrome) may be present. A history of nongonococcal urethritis in the male partner is associated with a 50% isolation of Chlamydia from the female partner. Neonates born to infected mothers have a 60% to 70% risk of infection, including a 10% to 20% risk of pneumonia and a 25% to 55% risk of conjunctivitis.

B. Physical examination.

Although the cervix may appear normal, there is often a significant increase in the incidence of cervical ectopy, erythema, and friability, as well as the presence of mucopus readily seen on a cotton-tipped swab. Mucopurulent cervicitis is caused by chlamydial infection in approximately 50% of cases.

C. Investigative procedures. Culture

is the only reliable way to establish the diagnosis. Endocervical samples are required and should be frozen if not cultured immediately. The organism must be grown in cell culture, and characteristic intracytoplasmic inclusions are identified after staining. If chlamydial cultures are not available, treatment should be given if the diagnosis is strongly suggested on clinical grounds. Direct tests for chlamydial antigen utilizing monoclonal antibodies, enzyme immunoassay, or a DNA probe are useful for screening high-prevalence populations. In low-prevalence groups, there are a significant number of false-positive results. Serologic testing is of little value.

D. Management.

Tetracycline, erythromycin, and azithromycin are highly effective, with cure rates approaching 95%. Additional drugs that have demonstrated activity against Chlamydia include sulfamethoxazole-trimethoprim, rifampin, clindamycin, ofloxacin, and amoxicillin.

The CDC-recommended regimens are azithromycin 1 g PO in a single dose or doxycycline, 100 mg PO bid for 7 days. Alternative regimens are ofloxacin, 300 mg PO bid for 7 days; erythromycin base, 500 mg PO qid for 7 days; erythromycin ethylsuccinate, 800 mg PO qid for 7 days; or sulfisoxazole, 500 mg PO qid for 10 days (this has inferior efficacy to other regimens) (3).

The CDC-recommended regimen for pregnant women azithromycin, 1 g PO or erythromycin base, 500 mg PO qid for 7 days. Alternative regimens include erythromycin base, 250 mg PO qid for 14 days or erythromycin ethylsuccinate, 800 mg PO qid for 7 days or 400 mg PO qid for 14 days. If erythromycin cannot be tolerated, amoxicillin, 500 mg PO tid for 7 to 10 days or clindamycin, 300 mg PO tid for 7 days, are recommended. Limited data exist on these regimens.

Sexual partners should be evaluated and treated.

Follow-up testing is unnecessary unless symptoms persist or reinfection is suspected. Pregnant patients, however, should be retested. At least 3 weeks must elapse after completion of therapy before retesting.

IV. Genital herpes simplex virus.

Venereal transmission through intercourse or orogenital contact is common for herpesvirus, a DNA virus. After the genital skin is inoculated, the virus infects peripheral nerve endings and travels to the lumbosacral dorsal root ganglia. A persistent, but subclinical, infection is established in the ganglion cells. Periodically, the virus becomes active and travels by peripheral nerves to the skin, inducing the characteristic focal recurrent lesion. Infections with herpesvirus type I or II are the most common cause of vesiculoulcerative lesions of the female genital tract. Type I generally causes oral lesions (fever blisters), and 75% to 80% of genital lesions are type II. However, these percentages vary with the population screened. About 50% to 70% of patients with primary infection experience recurrence. The attack rate (percentage of those who contract herpes simplex virus after exposure) for susceptible individuals is believed to be about 75%. There are an estimated 500,000 new cases in the United States annually, with more than 20 million episodes of recurrence.

A. History.

Incubation periods range from 1 to 30 days (median, 6–8 days). Generally, the presenting complaint is of blisters or ulcers on the vulva or severe vulvar pain. Much less often, severe dysuria, general malaise, fever, and enlarged inguinal nodes are the presenting features. The lesions typically evolve from vesicles to pustules to ulcers to crusts, with healing occurring over 14 to 21 days. They may be preceded by pruritus, burning, or hyperesthesia of the skin. Some patients may have no symptoms; thus it is not uncommon to miss the first infection. Recurrent infections are generally less severe than the primary infection and may be triggered by emotional stress, menses, intercourse, or may be totally unpredictable. Systemic symptoms rarely occur, and lesions last from 7 to 10 days. Recurrent lesions represent a reactivation of latent virus, not reinfection.

B. Physical examination.

Exquisitely sensitive vesicles and erosions of the labia, vaginal canal, perineum, and oropharynx may be found. Intense edema of the labia and urethra, as well as inguinal adenopathy may be present. Recurrent disease follows essentially the same course except that it is less debilitating, there are few ulcers, and adenopathy is seldom present. It is generally believed that there is no clinical difference between the lesions caused by the two virus types.

C. Investigative procedures.

The vesicles and ulcers characteristic of the disease are easily recognized, especially if there is a positive history. Cervical herpes virus is less obvious clinically. A Papanicolaou (Pap) smear of cervical herpes virus contains characteristic multinucleate giant cells in about 30% to 50% of patients. Definitive diagnosis can be confirmed by viral culture. Specimens should be taken using cotton-tipped or Dacron-tipped swabs placed in viral transport medium and held at 4°C until cultured. Direct detection of viral antigens using immunodiagnostic methods is available and provides sensitivities of 85% to 90%. These methods are much less sensitive in detecting asymptomatic viral shedding. Herpes virus antibodies appear within 4 days of primary infection and are present thereafter; therefore, they are not helpful in recurrent infection unless a change in titer is documented. Since herpesvirus is an STD, culture for gonorrhea and chlamydia infections and a serologic workup for syphilis, HIV, and hepatitis B and C should be obtained.

D. Management

General measures include keeping the vulva and perineum as dry as possible, wearing cotton underwear, and exposing the vulva to a heat lamp or a hair dryer, which may be soothing. Analgesics may be required because of pain and hypnotics may be required if there is interference with sleep. Occasionally, urinary retention may necessitate the use of an indwelling catheter. Sitz baths and local anesthetic creams may be helpful.

Specific measures. Oral acyclovir, valacyclovir, and famciclovir provide partial control of the symptoms and signs of herpes episodes but do not eradicate latent virus. Topical therapy is less effective and its use is discouraged. The CDC guidelines are as follows:

For first clinical episodes of genital herpes, the recommended regimen is acyclovir, 200 mg PO 5 times a day for 7 to 10 days or until clinical resolution. Alternatives are famciclovir 250 mg PO 3 times a day for 7 to 10 days or valacyclovir 1 g PO twice a day for 10 days. The dose of acyclovir is doubled for herpes proctitis and treatment is for 10 days, experience with famciclovir or valacyclovir in proctitis is lacking.

When treatment for recurrent episodes starts during the prodrome or within 2 days of lesion onset, limited benefit may result. The recommended regimen is acyclovir, 200 mg PO 5 times a day for 5 days or 400 mg PO tid for 5 days or 800 mg PO bid for 5 days. Drug therapy begun more than 2 days after onset of lesions has not been proven to be of benefit. Alternatives are famciclovir 125 mg PO twice a day for 5 days or valacyclovir 500 mg PO twice a day for 5 days.

Daily suppressive therapy reduces recurrences by at least 75% in patients having six or more episodes per year. Safety and efficacy have been reported for as long as 6 years. Asymptomatic viral shedding and the potential for transmission are not totally eliminated. After 1 year, therapy should be discontinued to reassess the rate of recurrence. The recommended regimen is acyclovir, 400 mg PO bid or famciclovir 250 mg PO bid or valacyclovir 500 mg PO bid or valacyclovir 1000 mg PO once a day.

For patients who have severe symptoms or complications that necessitate hospitalization, intravenous acyclovir shortens the median course of first episodes by approximately 7 days.

Acyclovir has not been adequately tested in pregnant or lactating women. Use in pregnancy is recommended only in the presence of life-threatening maternal infection. However, evidence of adverse effects has not been shown in ongoing registries, and therefore first clinical episodes in pregnancy may also be treated with acyclovir.

Patients should be counseled about the disease and advised to abstain from sexual intercourse while lesions are present. The risk of transmitting herpes simplex virus during asymptomatic periods is unknown. The use of condoms should be encouraged during all sexual exposures. Women also need to be instructed to inform their clinicians of their history of genital herpes early in pregnancy since serious neonatal infection may occur during parturition.

E. Sequelae.

In addition to a possible link with cervical neoplasia and neonatal infections, patients with the disease also have a high incidence of depression and sexual dysfunction. Much of the burden of this disease is of an emotional and social nature. Self-help groups, such as the American Social Health Association, may be of great assistance in helping herpes simplex virus patients cope with their problems.

V. Chancroid

is an ulcerating disease of the genital region caused by Haemophilus ducreyi. Its exact incidence is unknown, although clinical infection is rare in women. The incubation period is generally 4 to 7 days, the male to female ratio is 10:1.

A. CDC guidelines.

Chancroid is probably underreported because of the difficulty in proving the diagnosis. In an attempt to obtain more accurate incidence figures, the CDC has changed its reporting guidelines. The new case classification is:

Probable: a clinically compatible case with one or more painful genital ulcers and both

No evidence of T. pallidum by dark-field examination of ulcer exudate or by a serologic test for syphilis performed at least 7 days after the onset of ulcers.

Clinical presentation of the ulcer is not typical of a disease caused by herpes simplex virus, or an HSV culture is negative.

Confirmed: A case that is laboratory confirmed. Recently there has been a documented association of chancroid and HIV. The presence of HIV infection predisposes women to chancroid and increases the possibility of treatment failure.

B. History.

The patient usually presents with the complaint of a painful lesion.

C. Physical examination.

The initial lesion in women occurs on the fourchette, labia minora, urethra, cervix, or anus. Extragenital lesions may occur but are uncommon. Chancroid begins as an inflammatory pustule or papule that quickly ruptures to form a painful, nonindurated, shallow ulceration. Women tend to have multiple ulcers, with an average of four. The ulcer is 1 to 2 cm in diameter with ragged undermined edges, and the base is often covered with a purulent exudate. Approximately 1 week after the initial ulcer, lymphadenopathy, which is usually unilateral, develops in 50% of patients. This subsides without suppuration in more than half of the patients; however, if left untreated, the lymphadenitis may undergo unilocular suppuration. The involved nodes are inflamed and tender, and the overlying skin is erythematous. These nodes then break down, forming a single drainage sinus and/or fever may occur.

D. Investigative procedures

A presumptive diagnosis of chancroid may be made in the presence of a genital ulcer(s) with a negative examination for syphilis (dark-field examination, serologic tests, or both) and no evidence of herpesvirus during follow-up visits.

A definitive diagnosis is made by isolation of the organism from ulcers of lymph nodes on an appropriate selective medium, but the organism is difficult to culture.

DNA probes and the use of PCR may make diagnosis easier in the future.

E. Management

Drug therapy. Recommended regimens include azithromycin, 1 g orally; or ceftriaxone, 250 mg IM or ciprofloxacin, 500 mg PO bid for 3 days; or erythromycin, 500 mg PO qid for 7 days.

Fluctuant nodes should be aspirated through healthy adjacent skin as often as necessary to prevent the formation of a draining sinus. Incision and drainage of buboes may be necessary.

All sexual partners should be treated.

As with all STDs, examination should be undertaken for the presence of other STDs, HIV, and hepatitis B and C.

All patients should be counseled about the risk of transmitting chancroid and the risk of either transmitting or acquiring HIV and hepatitis B and C through sexual intercourse. Patients should be encouraged to abstain from intercourse until all lesions have healed. Condoms have also been shown to prevent the transmission of chancroid.

VI. Lymphogranuloma venereum

(LGV) is a granulomatous disease of the genital region that is primarily sexually transmitted. The causative organism is C. trachomatis, and the serotype is different from that which causes cervicitis. The incubation period is unknown. It is more common in men than women. LGV is rare in the United States, however, the actual prevalence is unknown.

A. History.

The presenting complaints may include a painless lesion, lymphadenopathy, lower abdominal pain, rectal bleeding, rectal purulent discharge, and proctitis with tenesmus, depending on the stage of development.

B. Physical examination

The initial lesion is a painless vesicopapule that appears on the external genitalia, vaginal walls, or cervix in women. It appears a few days to a few weeks after exposure. This quickly breaks down to form a small erosion that heals rapidly in men, but more slowly in women. As many as 50% of these lesions are asymptomatic and heal without scarring.

The secondary stage is characterized by lymphadenopathy, which is usually unilateral, but involves multiple nodes. This results in the formation of a large nodal mass with inflamed overlying skin. The involvement of inguinal and femoral nodes with a depressed area over the inguinal ligament (groove sign) is almost pathognomonic for LGV. These nodes then develop multiple foci of suppuration, followed by skin breakdown and formation of multiple draining sinuses (as opposed to chancroid, which has a single area of suppuration and one draining site). Genital mutilation often develops.

The inguinal adenopathy typically resolves after 2 to 3 months if untreated. However, in the tertiary stage involvement of internal nodes (perirectal and perivaginal) leads to an anorectal syndrome with lower abdominal complaints and proctitis with tenesmus, rectal bleeding, and a purulent discharge. This may lead to rectal strictures, elephantiasis of the labia, and rectovaginal fistulae. Although extragenital lesions are rare, LGV is associated with significant systemic signs such as fever, malaise, myalgias, and arthritis.

C. Investigative procedures

The diagnosis of LGV is best made by complement fixation titers, which are available through most laboratories. However, there is cross-reaction with other chlamydial serotypes. A fourfold increase in titer or a titer of greater than 1:64 should be considered diagnostic. A titer of 1:16 to 1:64 is suggestive, but can occur in individuals with other chlamydial infections. The organism can be recovered from nodal aspirations, but culture is technically difficult, expensive, and rarely available.

D. Management

Drug therapy. The recommended regimen is doxycycline 100 mg PO bid for 21 days. An alternative regimen is erythromycin 500 mg PO qid for 21 days.

As with chancroid, involved lymph nodes (buboes) should be aspirated through adjacent normal skin, and incision and drainage may be indicated.

Sexual contacts should be examined and treated.

Investigation for the presen

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