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Clinical Opinion www. AJOG .org GENERAL GYNECOLOGY A statement on abortion by 100 professors of obstetrics: 40 years later One Hundred Professors of Obstetrics and Gynecology F orty years ago, leaders in obstetrics and gynecology published a com- pelling statement that recognized the legalization of abortion in several states and anticipated the 1973 Supreme Court decision in Roe v Wade (Supplementary Data available at www.AJOG.org). 1 They projected the numbers of legal abortions that likely would be required by women in the United States and described the role of the teaching hospital in meeting that responsibility. 1 They wrote to ex- press their concern for women’s health in a new legal and medical era of re- productive control and to define the responsibilities of academic obstetrician- gynecologists. Since then, we have advanced the fields of reproduction and family planning. Thanks to these developments, women can now prevent pregnancy with safer and more effective forms of contracep- tion (most recently long-acting revers- ible methods), with simple and sensitive hormonal and sonographic methods to determine pregnancy status and dura- tion, and with new methods of infer- tility treatment and prenatal testing that rely on the option of terminating inten- ded pregnancies that are diagnosed as abnormal. To terminate pregnancies, cli- nicians now use misoprostol and mife- pristone for “medical abortion” (which in 2009 accounted for 16.5% of termina- tions in the United States and can be office-based) and use sonographic guid- ance of intrauterine procedures along with new methods for inducing cervical From the 100 Professors (Appendix). Received Dec. 3, 2012; revised Jan. 23, 2013; accepted March 7, 2013. The author reports no conflict of interest. Reprints not available from the authors. a 2013 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2013.03.007 In this Journal in 1972, 100 leaders in obstetrics and gynecology published a compelling statement that recognized the legalization of abortion in several states and anticipated the 1973 Supreme Court decision in Roe v Wade. They projected the numbers of legal abortions that likely would be required by women in the United States and described the role of the teaching hospital in meeting that responsibility. They wrote to express their concern for women’s health in a new legal and medical era of reproductive control and to define the responsibilities of academic obstetrician-gynecologists. Forty years later, 100 professors examine the statement of their predecessors in light of medical advances and legal changes and suggest a further course of action for obstetrician gynecologists. Key words: abortion, law, teaching hospital dilation and uterine contraction; patients benefit from innovations in counseling and new approaches to pain control. 2-6 Studies of abortion practice and out- comes are also much more sophisticated than they were 40 years ago. 7,8 We have had 40 years of medical progress but have witnessed political regression that the 100 professors did not anticipate. In 2011 alone, 24 states passed 92 legislative restrictions on abortion. 9 Waiting periods after consent are now law in 26 states. Alabama, Arizona, Florida, Kansas, Louisiana, North Car- olina, Oklahoma, and Texas require pa- tients to view ultrasound images and, in Arizona, Louisiana, Mississippi, and Texas, to listen to fetal heart beats. 10 Laws in 27 states force physicians to provide deceptive counseling including false statements about risks of breast cancer, infertility, and mental health. They include laws to limit second-trimester abortion under the guise of protecting the fetus from pain (Alabama, Idaho, Indiana, Kansas, Louisiana, Nebraska, and Oklahoma). 11 Laws directed specif- ically at medical education in Arizona, Kansas, and Texas prohibit abortion training in public institutions and another 7 states ban abortion in public hospitals, precluding training in them. 12 What vision of the future of legalized abortion did the 100 professors have? How accurately did they estimate the need for safe, legal abortion and antici- pate their colleagues’ willingness and commitment to meeting it? They wrote, “In view of the impending change in abortion practices generated by new state legislation and federal court de- cisions, we believe it helpful to [respond] to this increasingly liberal course of events.by contributing to the solution of an imminent problem.” 1 Forty years later, the change is not liberal. Its effects will threaten, not improve, women’s health and already obstruct physicians’ evidence-based and patient-centered practices. We review our predecessors’ 1972 statement and judge how it com- ports with what actually occurred and with legislation that has been adopted over the 40 years since their writing and the passage of Roe v Wade. The 100 professors were remarkably prescient in anticipating the need for 1 million legal abortions and today’s abortion rate of 1 in 4 pregnancies. 13,14 They predicted that teaching hospitals with specialized outpatient facilities could meet the demand and believed that abortions were the responsibility of hospitals. But today, 90% of abortions, which include the 10% that are in the second trimester, are done away from hospitals. 15 Many hospitals enforce fetal and maternal health restrictions that SEPTEMBER 2013 American Journal of Obstetrics & Gynecology

Sponsored by the nonprofit Berlex Foundation, this 6-day Faculty Development Course introduces small groups of new faculty to research design, critical appraisal of the literature, scientific writing, and evidence-based medicine. The course includes didactic presentations, small group discussions, and individual protocol development. Its influence on academic careers is impossible to determine, because defining an appropriate comparison group is not feasible. However, the cumulative effect should be to increase the research expertise of some young faculty in academic departments nationwide. In addition, many participants have introduced the principles of evidence-based medicine in their own teaching programs.

Luteal phase deficiency is thought to be a cause of female infertility. Nevertheless, little agreement exists concerning either its diagnosis or its treatment. To address the latter question, we reviewed the English literature and examined the effect of treatment on pregnancy rates. One randomized controlled trial found a statistically insignificant benefit of treatment with progesterone suppositories or oral dehydroprogesterone versus no treatment (relative risk 1.9; 95% confidence interval 0.4 to 8.1). Three other comparative studies also showed no statistically significant benefit. Case-series reports (before-after studies) claiming benefit failed to account for the effect of regression to the mean. The benefit of treatment for luteal phase deficiency has not been established. Uniform case definitions and randomized controlled trials of adequate power are needed to resolve this problem.

From 1977 to 1988, an epidemic of antiabortion violence took place in the United States, involving 110 cases of arson, firebombing, or bombing. The epidemic peaked in 1984, when there were 29 attacks. Nearly all sites (98%) were clinics that provided abortions. Facilities in 28 states and the District of Columbia were involved. The national rate of violence was 3.7 per 100 abortion providers and 7.2 per 100 nonhospital abortion providers. The national ratio of violence per 100,000 abortions performed was 0.6 Arson was both the most frequent (39% of all cases) and the most damaging (mean cost $141,000) type of violence. The epidemic appears partially attributable to multiple point-source outbreaks of violence caused by small numbers of individuals or groups. Thirty-three persons have been convicted to date. Vigorous prosecution of perpetrators and the reemergence of clinics after damage probably helped to curb the epidemic.Between 1977-88 there was an epidemic of violence directed against abortion clinics. These attacks consisted of 110 cases of arson, firebombing, or bombing. In 1984 the epidemic reached a peak with 29 attacks. 98% of the sites were clinics that provided abortion services. This study surveys the frequency of attacks per states based on 3 different denominators: 1) number of abortion providers, 2) cumulative number of abortions performed from 1977-88, 3) estimated number of women in the 15-44 age group as of July 1, 1982. During the study period 1977-88, the National Abortion Federation reported the following violent acts against clinics: 222 clinic invasions, 220 acts of clinic vandalism, 216 bomb threats, 65 death threats, 46 assault and batteries, 20 burglaries, and 2 kidnapings. Vigorous investigation and convictions have slowed the epidemic. The longest sentence handed down was 30 years and the largest fine was $350,000. The biggest effect it has had is financial. The direct cost is $7.6 million, but this does not include the cost of clinics that were destroyed and not rebuilt. It does not include the cost of related expenses for lawyers and security, increased insurance, new licensing requirements, and staff recruitment. Also, lost time waiting for repairs and rescheduling of patients to other facilities are not included in this figure. Violence of this nature does nothing to end the debate over abortion, it also does not reduce the number of abortions. It only raises the cost of abortion, and inconveniences women seeking abortion. Sex education, personal responsibility, and more widespread and effective contraceptive use would all reduce the need for abortion.

The comparative safety of pregnancy outcomes has clinical and public health importance. Using national statistics for 1991 to 1999, I estimated the risk of maternal death associated with various outcomes. Abortion (legal and spontaneous) was associated with the lowest risk, live birth intermediate risk, and ectopic pregnancy and fetal death the highest risk.

Fires and unintended pregnancies are important causes of morbidity, mortality, and financial loss in the United States. Home fire extinguishers and emergency contraception are both effective preventive interventions. The disparity between access to fire extinguishers and emergency contraception is irrational and indirectly hurts women's health. Although fire extinguishers require the user to make a diagnosis, choose the appropriate treatment, and assume some risk of serious injury and death, these canisters of pressurized chemicals are widely available without restriction. In contrast, women face several unnecessary obstacles to overcome before using emergency contraception, which is both simpler and safer to use. Clearly, a double standard prevails in prevention strategies for women. The Food and Drug Administration should approve over-the-counter availability of emergency contraception without further study or delay.

Modern hormonal contraceptives and intrauterine contraceptive devices have multiple biologic effects. Some of them may be the primary mechanism of contraceptive action, whereas others are secondary. For combined oral contraceptives and progestin-only methods, the main mechanisms are ovulation inhibition and changes in the cervical mucus that inhibit sperm penetration. The hormonal methods, particularly the low-dose progestin-only products and emergency contraceptive pills, have effects on the endometrium that, theoretically, could affect implantation. However, no scientific evidence indicates that prevention of implantation actually results from the use of these methods. Once pregnancy begins, none of these methods has an abortifacient action. The precise mechanism of intrauterine contraceptive devices is unclear. Current evidence indicates they exert their primary effect before fertilization, reducing the opportunity of sperm to fertilize an ovum.The mechanism of action of contraceptive method is essential for the development of new methods. It also influences cultural and individual acceptability of a contraceptive method. Modern hormonal contraceptives and intrauterine contraceptive devices have multiple biologic effects. Some of them may be the primary mechanism of contraceptive action, whereas others are secondary. For the combined oral contraceptives and progestin-only methods, the main mechanism of action are the inhibition of follicular development, ovulation, and as consequence, corpus luteum formation. Further, it is also involved in the alteration of the cervical mucus that inhibit sperm penetration. For hormonal methods, particularly the low-dose progestin-only products and emergency contraceptive pills have effects on the endometrium that, theoretically, could affect implantation. However, no scientific evidence will indicate that prevention of implantation actually results from the use of these methods. Once implantation has taken place, none of these methods are effective and pregnancy proceeds normally. The precise mechanism of IUDs remains unclear because of difficulties in carrying out relevant investigations in humans and the limitations of extrapolating findings from animal studies. However, several studies evidenced that IUDs exert their primary effect before fertilization, by impeding the ascent of sperm to the fallopian tubes or by reducing the ability of sperm to fertilize an ovum.

Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references.We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria.Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials.Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.

A shift from treatment to prevention of the three major gynecologic cancers is overdue. The traditional approach to cervical, endometrial, and ovarian cancers has been secondary or tertiary prevention--early detection and treatment or mitigation of damage, respectively. We reviewed the literature on these cancers to identify strategies for primary prevention. Cervical cancer behaves as a sexually transmitted disease. As with other such diseases, barrier and spermicidal contraceptives lower the risk of cervical cancer; the risk reduction approximates 50%. Combination oral contraceptives help prevent both endometrial and epithelial ovarian cancers. The risk of endometrial cancer among former oral contraceptive users is reduced by about 50% and that of ovarian cancer by about 30% to 60%. Weight control confers strong protection against endometrial cancer. Breast-feeding and tubal sterilization also appear to protect against ovarian cancer. Although women have a range of practical, effective measures available to reduce their risk of these cancers, few are aware of them. Without this information, women cannot make fully informed decisions about their health.

Because oral contraceptives are used by tens of millions of healthy women, their safety for short-term and long-term use is an important issue that has been examined in a large number of epidemiologic studies. These studies have become more rigorous and have increased in size and analytic sophistication over the years. Although breast cancer remains the most important safety concern, the bulk of recent data suggests that oral contraceptives have no overall impact on a woman's risk of developing this disease. The results are less clear on the risk of cervical cancer and its precursors because of methodologic problems. However, the newer oral contraceptive formulations no longer appear to be associated with an increased risk of myocardial infarction or stroke.Studies show that OCs have several benefits besides prevention of pregnancy. They protect against ovarian and endometrial cancer, pelvic inflammatory disease, and ectopic pregnancy. OCs also prevent iron deficiency anemia, primary dysmenorrhea, functional ovarian cysts, and benign breast disease. They may even protect against some benign uterine tumors, osteoporosis, toxic shock syndrome, and rheumatoid arthritis. Despite many concerns, some large studies have not identified an overall effect of OCs on breast cancer, but subgroup analyses showed increased risk in 30-34 year old women and in women with 1 child. A reanalysis of a large US study indicated an increase risk of breast cancer in nulliparous women with increasing use of OCs by young women. Cervical cancer is the leading cancer of women in developing countries which emphasizes the need to examine the link between OC use and cervical cancer. Several studies show an increased risk of cervical cancer. Several studies show an increased risk of cervical cancer in long term OC users. In 1 study, long term use meant 5 years. Yet these studies did not adequately address confounding factors such as smoking and sexual behavior. 3 case control studies in the US and the UK found an increased risk of liver cancer among OC users, yet a large case control study in developing countries did not find a link between OC use and liver cancer. Studies of high dose OCs found considerable increased risks of cardiovascular disease in OC users, but they did not take into account cigarette smoking which indeed increases the risk. Further health practitioners today do a more thorough job of identifying underlying medical problems before prescribing OCs. Moreover estrogen doses have fallen 10 fold since the original OCs. Finally, despite a transient delay, women who take OCs experience a return to fertility at the same rate as those who use other contraceptives.

OBJECTIVES: This report reviews the evidence supporting the use of operative laparoscopy for a number of expanded indications in gynecology. STUDY DESIGN: Studies published in English were identified through a Medline search back to 1966 for literature listed under the medical subject heading of "peritoneoscopy"; this search was supplemented by reviews of reference lists and discussions with experts. RESULTS: Fair evidence exists to recommend use of laparoscopy for ectopic pregnancy, ovarian biopsy, and treatment of polycystic ovarian syndrome resistant to clomiphene citrate therapy. Evidence concerning other indications is inadequate to allow recommendations. CONCLUSION: Mechanisms are urgently needed to evaluate surgical innovations in gynecology with the same degree of scientific rigor currently afforded medical innovations. Without surgical technology assessment, the current double standards in gynecologic therapy will persist.

Induced abortion is a common event in the lives of women and their families. Statistics show that in the US nearly half of all women personally benefit from abortion; hence abortion is important from both a medical and a social standpoint. During the 1900s, anti-abortion laws were promulgated, subsequently resulting in the rise of maternal mortality due to complications from unsafe abortions. In the mid-1960s, state laws began to change to allow women access to safe abortions provided by licensed physicians. Since then, deaths from illegal abortions have decreased substantially. It is noted that legal abortion is one of the safest operations in contemporary medical practice, and its safety has improved through the years. Surgical skills have been enhanced and the technologies of suction curettage abortion and dilatation and evacuation introduced. In addition, abortion techniques using prostaglandin, mifepristone, methotrexate, and misoprostol have advanced.

The intrauterine device is a safe, highly effective, long-lasting, yet reversible method of contraception. Expanding access to intrauterine contraception is an important measure to reduce the rate of unintended pregnancy in the United States. Clinicians should consider intrauterine contraception in appropriate candidates, including women who are nulliparous, adolescent, immediately postpartum or postabortal, and desiring emergency contraception, and as an alternative to permanent sterilization. Barriers to intrauterine contraception such as requiring cervical cancer screening before insertion, routine testing for gonorrhea and chlamydial infection in low-risk women, or scheduling insertion only during menses are unnecessary.

A patient treated with mifepristone (RU 486), which successfully induced abortion of an intrauterine pregnancy, was discovered to have a heterotopic ovarian pregnancy resistant to this antiprogesterone. The ovarian pregnancy was removed with operative laparoscopy. This case demonstrates for the first time that an ovarian pregnancy may be resistant to treatment with RU 486 at a dose adequate to abort an intrauterine pregnancy.

Summary The experience of 271 patients who received mifepristone (RU 486) in experimental protocols from July 1984 to January 1989 was analyzed by logistic regression methods. The regimen used was the strongest predictor of failure, followed by Quetelet's index and initial B-human chorionic gonadotropin level. The relative risk of failure was 2.3 times with 7-day regimens and 6.3 times with the other regimens that obtained with regimens of 600 mg given once or twice. The relative risk of failure increased with increasing Quetelet's index; women in the top quartile were 2.9 times more likely to fail to abort than were women in the bottom quartile. The risk of failure increased with increasing initial ß-human chorionic gonadotropin level; those with an initial level > 19,800 mlU/ml were 2.8 times more likely to fail to abort than were women with an initial value ⪯ 6350 mill/ml. Body mass appears to influence the likelihood of abortion with mifepristone. (Am J Obstet Gynecol 1990;162:910-7.)

A patient with subacute incomplete uterine inversion was transferred to our hospital when the diagnosis was made 5 days after vaginal delivery. Intravenous injection of sodium fluorescein dye identified a clear demarcation between viable and necrotic myometrium. The superior aspect of the uterus was infarcted; therefore a hysterectomy was performed.

Previous reports examining adnexal torsion suggested that benign ovarian neoplasms are more likely to undergo torsion than malignant ovarian neoplasms. To our knowledge, this clinical observation has not been quantified. To examine this hypothesis, we reviewed our experience with ovarian neoplasms found at the time of surgery over a 10-year period. Benign ovarian neoplasms had a 12.9-fold increased risk of undergoing adnexal torsion when compared with malignant ovarian neoplasms (95% confidence interval, 10.2 to 15.9). The histologic type of ovarian neoplasm does not appear to affect the rate of adnexal torsion. Adnexal torsion rarely involves cancer.

Different methodologic approaches have resulted in a wide variability in the reported incidence of hydatidiform mole in the United States. We studied the epidemiology of hydatidiform mole among 84,318 women obtaining legal abortions in the United States during the period 1975 to 1978. Our estimated rate of 7.5 hydatidiform moles per 10,000 pregnancies was similar to most reported rates for the United States. The rate was significantly higher for women 14 years or younger and those 45 years or older. Race, number of previous pregnancies, and number of previous spontaneous abortions were not found to significantly affect the risk of having the disease. The incidence was slightly (but not significantly) higher for women obtaining abortions during the first trimester than for those obtaining abortions during later gestation. This study minimizes the errors encountered in estimating the total number of pregnancies and the number of hydatidiform moles at later stages of gestation. Hydatidiform mole, although relatively the number of hydatidiform moles at later stages of gestation. Hydatidiform mole, although relatively uncommon, represents a complication of pregnancy that is of public health importance.

We examined the age, gestational age, parity, race, and number of previous spontaneous and induced abortions of 82,030 women who obtained abortions at less than or equal to 24 weeks' gestation. Among these women, 342 (0.4%) had serious complications, including 130 (0.2%) with fever greater than or equal to 38 degrees C for 3 or more days, 172 (0.2%) who required transfusions, 67 (0.1%) who required unintended surgery, and three who died. Factors significantly (p less than 0.05) associated with serious complications varied by period of gestation, including previous induced abortions (adjusted relative risk = 1.57, 95% confidence interval = 1.03 to 2.40) for procedures done at less than or equal to 12 weeks' gestation, advancing age (relative risk for a 5-year increment = 1.12, 95% confidence interval = 1.01 to 1.24), and advancing gestational age (relative risk for a 2-week increment = 1.50, 95% confidence interval = 1.43 to 1.57) for procedures done at greater than 12 weeks, and greater than or equal to 1 previous delivery (relative risk = 1.34, 95% confidence interval = 1.03 to 1.75) for all gestational ages. Although Hispanic women had higher rates of complications compared with white women, data were not available to control for socioeconomic status in comparing race groups. There was no significant association between previous spontaneous abortions and serious complications. Risk patterns were similar, but not identical, when fever, operation, and transfusion were considered separately.The authors examined the age, gestational age, parity, race, and number of previous spontaneous and induced abortions of 82,030 women who obtained abortions at less than 24 weeks' gestation. Among these women, 342 (0.4%) had serious complications, including 130 (0.2%) with fever of over 38 degrees Centigrade for 3 or more days, 172 (0.2%) who required transfusions, 67 (0.1%) who requied unintended surgery, and 3 who died. Factors significantly (p 0.05) associated with serious complications varied by period of gestation, including previous induced abortions (adjusted relative risk = 1.57, 95% confidence interval = 1.03 to 2.40) for procedures done at less than 12 weeks' gestation, advancing age (relative risk for a 5-year increment = 1.12, 95% confidence interval = 1.01 to 1.24), and advancing gestational age (relative risk for a 2-week increment = 1.50, 95% confidence interval = 1.43 to 1.57) for procedures done at more than 12 weeks, and moe than 1 previous delivery (relative risk = 1.34, 95% confidence interval = 1.03 to 1.75) for all gestational ages. Although Hispanic women had higher rates of complications compared with white women, data were not available to control for socioeconoimic status in comparing race groups. There was no significant association between previous spontaneous abortions and serious complications. Risk patterns were similar but not identical when fever, operation, and transfusion were considered separately.

An intramuscular dose schedule of 15(S)-15-methyl-prostaglandin E2-methyl ester (15-(S)-ME PGE2) was evaluated for its application as a midtrimester abortifacient route. 20 healthy gravidas aged 18-42 years and 8-22 menstrual weeks of gestation were aborted in the Clinical Research Unit of the University of North Carolina Memorial Hospital. The subjects were given 5 mcg of the PGE2 methyl ester every 4 hours. 85% (17/20) aborted within 48 hours, 65% (13/20) of these within 24 hours. Mean induction-abortion interval was 21 hours. Trials were defined as complete in 55%, incomplete in 30%, and failure in 15%. Shivering, fever, pain, vomiting, and diarrhea were the most common side effects. The transient shivering occurred in 13 (65%) of the subjects within 20 minutes of the first dose. Fever usually started after shivering, and both resolved spontaneously. 2 patients had estimated blood loss exceeding 500 ml, but they were not given transfusions. No clinically significant changes occurred in mean hemotocrit, platelet count, serum creatinine, bilirubin, alkaline phosphatase, electrolytes, serum glutamic oxalacetic transaminase, and serum glutamic pyruvic transaminase. Mean blood cell and neutrophil counts increased, but neither increase was statistically significant.

To identify risk factors for febrile complications after suction curettage abortion, we analyzed the data of 26,332 women who underwent suction curettage abortion at five participating centers in the Joint Program for the Study of Abortion, Part III, from 1975 to 1978. We defined febrile morbidity as an oral temperature of greater than or equal to 38 degrees C for 2 days or longer. The febrile morbidity rate was 0.34 per 100 abortions. We performed a multivariate analysis using a linear logistic regression model. Prophylactic antibiotics proved to be the most protective factor, reducing the rate of febrile complications to about one third that of women who received no prophylactic antibiotics (relative risk 0.36; 95% confidence interval 0.18 to 0.70). Patients who had had one or more previous births also had a significantly lower risk of febrile morbidity (relative risk 0.54; 95% confidence interval 0.33 to 0.88). Other factors did not significantly affect the febrile complication rate.To identify risk factors for febrile complications after suction curettage abortion, the authors analyzed the data of 26,332 women who underwent suction curettage abortion at 5 participating centers in the Joint Program for the Study of Abortion, Part III, from 1975-76. Febrile morbidity was defined as an oral temperature of greater than 38 degrees Centigrade for 2 days or longer. The febrile morbidity rate was 0.34/100 abortions. A multivariate analysis was performed using a linear logistic regression model. Prophylactic antibiotics proved to be the most protective factor, reducing the rate of febrile complications to about 1/3 that of women who received no prophylactic antibiotics (relative risk 0.36; 95% confidence interval 0.18-0.70). Patients who had had 1 or more previous births also had a significantly lower risk of febrile morbidity (relative risk 0.54; 95% confidence interval 0.33-0.88). Other factors did not significantly affect the febrile complication rate.

The epidemiology of gestational trophoblastic disease is not well understood. Methodologic problems with published reports limit the interpretation of incidence data, although the frequency of hydatidiform mole appears to be about one per 1000 pregnancies. No consistent temporal trends in rates of either hydatidiform mole or choriocarcinoma are evident. Hydatidiform mole appears to be caused by abnormal gametogenesis and fertilization. Age, ethnicity, and a history of hydatidiform mole appear to be important risk factors for hydatidiform mole. Age, ethnicity, a history of hydatidiform mole or fetal wastage, and ABO blood group interactions appear to be important risk factors for choriocarcinoma. Future studies should focus on the mechanisms by which these risk factors influence gametogenesis, fertilization, and malignant transformation of trophoblastic tissue.

The basis of the clinical tenet that abortions by dilatation and evacuation should not be performed after 12 menstrual weeks' gestation is elusive. For women requesting abortions after 12 weeks' gestation, instillation techniques and the requisite delay until 16 weeks' gestation or later appear to be costly—medically, economically, and emotionally. A substantial body of epidemiologic data refutes the 12 week ceiling, but randomized clinical trials may be needed to establish an appropriate gestational age limit for evacuation abortion, if such a limit is necessary.

Although complications of anesthesia are now the leading cause of death from abortion at ≤ 12 weeks' gestation, the comparative risk of death from abortions performed with local versus general anesthesia is unknown. To estimate this risk for both anesthesia-related and nonanesthesia-related legal abortion deaths at ≤ 12 weeks' gestation, we used 1972–1977 data from the Center for Disease Control and the Alan Guttmacher Institute. When adjusted for preexisting disease and concurrent sterilization, the death-to-case rate for abortions at ≤ 12 weeks' gestation associated with general anesthesia was 0.37 deaths/100,000 abortions, and the rate with local anesthesia was 0.15/100,000. For nonanesthesia-related deaths, the comparable adjusted rates were 0.49 and 0.28, respectively. Use of general anesthesia is associated with a twofold to fourfold increased risk of death from abortion at ≤ 12 weeks' gestation.

Amniotic fluid embolism (AFE) has emerged as an important cause of death from legally induced abortion. In the period 1972-1978, 12 probably and three autopsy-confirmed cases of fatal AFE during legally induced abortion were identified in the United States (12% of all deaths from legal abortion). Fourteen deaths from AFE were associated with labor-inducing techniques, and one with hysterotomy. The risk of death appears to be related to gestational age: the death-to-case rate for AFE increases progressively from nil at less than or equal to 12 weeks' gestation to 7.2 deaths per 100,000 abortions at greater than or equal to 21 weeks' gestation. Because treatment is frequently ineffective, prevention of AFE is critical. Performing abortions early in pregnancy and using curettage techniques whenever feasible should reduce the risk of death from this obstetric accident during legally induced abortion.Amniotic fluid embolism (AFE) has increased in importance as a cause of maternal death. During 1968-75 454 women died of AFE in the U.S., or 9% of all maternal deaths. AFE has recently been found to be an important cause of abortion-related deaths; since 1972 AFE has accounted for 12% of all deaths related to legally induced abortion; the overall estimated death-to-case rate for AFE is 0.2/100.000 legal abortions. 15 cases of fatal AFE associated with legally induced abortion were reported in 1978-79, according to the Center for Disease Controls; 3 of these cases were confirmed by autopsy. Age ranged from 16 to 35 years; 7 patients were white, 6 blacks, and 2 were Asian. Gestational age went from 14 to 35 weeks. 5 women had preexisting conditions; 14 women underwent instillation of hypertonic solution, hyperosmolar urea, or PGF2alpha; 1 woman underwent hysterotomy. All women were in labor when manifestations of AFE became evident; death usually occurred soon after the appearance of signs. Risk of death from AFE seems to increase progressively with advancing gestational age; risk at 21 weeks gestation is about 24 times higher than from abortion at 13-15 weeks' gestation. During the same period of time no deaths were associated with curettage abortions. Estimated death-to-case rate for instillation was not significantly different than for hysterotomy; the estimated death-to-case rate for black women and minority women was 2 times higher than for white women. Age did not make a difference in relationship to death. AFE is caused by the forcing of amniotic fluid into the maternal vascular system during the period of intense uterine contractions. The amount of amniotic fluid is much larger during the second and third trimester of pregnancy; this probably explains the increased risk of death from AFE afer 12 weeks' gestation. Prevention rather than treatment of AFE is of paramount importance. 2 measures may reduce the risk of abortion-related AFE: 1) abortion before the 12-15 week, and 2) curettage at about 13 weeks' gestation. Curettage, presumably by avoiding labor contractions, lowers the risk of AFE.

Both non-abortion-related maternal and abortion-related mortality declined prior to the Supreme Court decisions of 1973. In order to determine the effect of legalized abortion on maternal mortality, we have analyzed the secular trends in national abortion mortality ratios for 1940 through 1976, compared the trends to those maternal mortality ratios, and hypothesized reasons for differences between these trends. Between 1940 and 1950 and after 1965, deaths from abortion declined more rapidly than deaths from other causes associated with childbirth. However, between 1951 and 1965, maternal mortality related to pregnancy of childbirth declined more rapidly than abortion-related mortality. Five possible explanations exist for the more rapid decline in abortion deaths since 1965--selected underreporting, changes in coding practices, improved safety of illegal abortion, introduction of more effective contraception, and increased availability of legal abortion. We consider the last two explanations as the most likely reasons for the accelerated decline in abortion-related deaths.Both non-abortion-related maternal and abortion-related mortality have declined in the U.S. Between 1940-1950 and after 1965, deaths from abortion declined more rapidly than deaths from other pregnancy and birth-related causes. 1970-1976 average annual rate, 25%). Between 1951-1965, maternal mortality related to pregnancy or childbirth declined more rapidly than abortion-related mortality (average annual rate, 13% until 1965, and 5% thereafter). It is suggested that 5 reasons exist which explain the decline in abortion deaths since 1965: 1) increased use of effective contraceptives, 2) availability of legal abortions, 3) possibility of increased safety of illegal abortion, 4) selected underreporting, and 5) changes in coding practices.

RU-486 is a synthetic progesterone antagonist that is abortifacient in early pregnancy. This trial evaluated the effectiveness and safety of a single 600 mg oral dose given to 50 healthy women less than or equal to 49 days from their last menstrual period. Efficacy was inversely related to the initial beta-subunit of human chorionic gonadotropin level, ranging from 100% at less than 5000 mIU/ml to 81% at greater than 20,000 mIU/ml (p less than 0.05). Uterine bleeding was the most serious side effect. However, the mean change in the hemoglobin value 14 days after treatment was -0.4 gm/dl, and no patient required blood transfusion. This regimen appears to be simple, effective, and safe.

Primary prevention of sexually transmitted diseases has received little emphasis in control programs. To evaluate the effectiveness of prevention strategies, we reviewed the world's literature on this topic. Use of condoms and spermicides greatly reduces the risk of gonorrhea, and barrier methods are practical and acceptable. Certain systemic antibiotics are effective, but for practical reasons, their use cannot be recommended. Washing or urinating after sexual exposure does not appear to protect againt infection. Although the effectiveness of modifying sexual behavior to reduce the risk of sexually transmitted diseases has not been evaluated, many people have changed or are willing to change their behavior. Even if preventive measures are used consistently by only a minority of persons at risk, rates of sexually transmitted diseases would decline rapidly. In this era of sexually transmitted diseases that are not readily cured by antibiotics, use of effective preventive measures should be strongly encouraged.

The relative risks of coagulopathy from suction curettage, dilatation and evacuation (D and E), and saline instillation were examined using the records of all women obtaining abortions at the Inglewood Hospital in California from February 1980-September 1981. Abortion-related coagulopathy cases were defined as those having both clinical evidence of nonclotting hemorrhage and laboratory confirmation of lower than expected fibrinogen levels (200 mg/dl). During the study period, 13,272 abortions were done by suction curettage, 2619 by D and E, and 304 by saline instillation. 8 cases of coagulopathy were identified. 1 case was associated with suction curettage, 2 with saline instillation, and 5 with D and E. The rates for coagulopathy/100,000 procedures were 8 for suction curettage, 191 for D and E, and 658 for saline instillation. Compared with that of suction curettage, the relative risk of coagulopathy associated with D and E was 25 and of saline instillation, 87, both statistically significant. The relative risk associated with saline instillation versus D and E was 3.4, not statistically significant. The study presents the experience of a single institution with a single group of similarly trained physicians, and uses uniform diagnostic criteria for coagulopathy, but the findings were based on the experience of a limited patient population and the demographic characteristics of the 16,195 women were unavailable, so that potential confounders such as age and parity could not be controlled. Large series are required to define more precisely the risk of coagulopathy for the various abortion methods.

Cardiovascular disease poses a major threat to women's health. Obstetrician-gynecologists dominate the adult health care field in preventive services in the United States, and the scope of their preventive services should be broadened to encompass cardiovascular disease in women. Endogenous and exogenous risk factors jointly conyribute to a woman's cardiovascular risk profile; the risk of cardiovascular disease should be viewed as a multifactorial phenomenon with a continuous gradient of response. Three important risk factors—serum cholesterol, hypertension, and cigarette smoking—are amenable to change and should become a principal focus of women's health care. Although preventive medicine lacks the glamour and immediate rewards of obstetric and gynecologic interventions, the long-term benefits to the health of women are compelling.

Clinicians have debated whether women who request permanent sterilization when they undergo elective abortion should have the two operations done concurrently. Moreover, if the procedures are performed concurrently, the appropriate surgical approach is unknown. To evaluate the latter issue, we identified all concurrent abortion-sterilization deaths in the United States in the period 1972 to 1978 from the Centers for Disease Control's nationwide surveillance of abortion mortality and divided them into two groups: those who had hysterotomy with tubal ligation or hysterectomy (H/H) and those who had curettage or instillation procedures, with tubal ligation by laparoscopy or laparotomy (other procedures). We then used data from the Joint Program for the Study of Abortion (JPSA/CDC) to estimate the number of procedures done in the United States in the period 1972 to 1978 and calculated death-to-case rates for each group. We found that the risk of dying from a concurrent abortion-sterilization procedure was 3.3 times higher if done by H/H. The relative risk for this group was highest during the first 12 weeks of gestation (4.6) and lowest at 13 weeks or later (1.3), regardless of the presence or absence of preexisting medical conditions. Except in the rare instances where the woman has an indication for hysterectomy other than fertility control, the performance of hysterectomy or hysterotomy for concurrent abortion-sterilization, particularly at less than 13 weeks' gestation, does not appear justified.

Legal abortion has been postulated to be a risk factor for placenta previa in subsequent pregnancies. To examine this hypothesis, we analyzed the deliveries of 28,665 women. We identified 68 women who had had placenta previa and compared their obstetric histories with those of 68 controls randomly selected from the same group of deliveries. The crude risk ratio for women with a history of one or more legal abortions was 1.4 (95% confidence interval, 0.5 to 3.6; p greater than 0.05). Standardizing the crude risk ratio for the effects of age and gravidity reduced the risk ratio to 1.1 (95% confidence interval, 0.4 to 2.8). In this predominantly black population legal abortion does not appear to have a significant association with placenta previa in subsequent pregnancies.Legal abortion has been postulated to be a risk factor for placenta previa in subsequent pregnancies. To examine this hypothesis, we analyzed the deliveries of 28,665 women. We identified 68 women who had had placenta previa and compared their obstetric histories with those of 68 controls randomly selected from the same group of deliveries. The crude risk ratio for women with a history of 1 or more legal abortions was 1.4 (95% confidence interval, 0.5-3.6; p 0.05). Standardizing the crude risk ratio for the effects of age and gravidity reduced the risk ratio to 1.1 (95% confidence interval, 0.4-2.8). In this predominantly black population, legal abortion does not appear to have a significant association with placenta previa in subsequent pregnancies.

Systemic lupus erythematosus characteristically afflicts women of reproductive age, yet the explanation for this feature is unknown. This hospital-based, case-control study of 109 incident cases of systemic lupus erythematosus and 109 randomly selected controls was conducted to search for risk factors related to reproduction. Women who were 34 years of age and younger had a crude risk of systemic lupus erythematosus 3.6 times that of older women, and women who were of minority races had a crude risk 4.8 times that of white women (P less than 0.001). Prior hysterectomy or tubal sterilization had a significant protective effect (odds ratio, 0.55; 95% confidence interval, 0.31 to 0.99). Endometriosis was associated with a twofold increased risk of systemic lupus erythematosus, although this was not statistically significant. The latter two findings are consistent with the hypothesis that retrograde menstruation may be an inciting factor for systemic lupus erythematosus in susceptible women.

Diagnostic dilation and curettage (D&C) is widely considered to be the method of choice for obtaining samples of endometrium for histologic examination, although the scientific basis for this assumption is elusive. Despite extensive use of D&C, the tissue yield and diagnostic accuracy of this technique have not been adequately evaluated. More is known about these features of a newer diagnostic procedure, Vabra aspiration (VA). VA also appears to be safer, less expensive, and more convenient than D&C. Until the alleged benefits of diagnostic D&C can be shown to outweigh its risks and costs (approaching one billion dollars per year in the United States alone), D&C probably should not be the primary procedure used for obtaining most samples of endometrium.

Six abortion-related deaths associated with the use of prostaglandin F2alpha were reported through the Center for Disease Control's surveillance of abortion deaths between 1972 and 1975. Prostaglandin may have had only indirect association with these deaths. The patients' ages ranged from 16 to 38 years, their length of gestation ranged from 15 to 24 menstrual weeks, four were white, and three were nulliparous. Four patients had pre-existing conditions that increased their risks and contributed to their death. The estimated death-to-case rate for prostaglandin F2alpha was 10.5 per 100,000 abortions. Although lower than the rate for intra-amniotic saline instillation, this death-to-case rate is only an approximation. The relative safety of intra-amniotic prostaglandin F2alpha as a second-trimester abortifacient, compared to saline, remains to be established.

Authorities have suggested use of a combination of hyperosmolar urea and low-dose prostaglandin F2 alpha as a second-trimester intra-amniotic abortifacient to avoid the disadvantages of hypertonic saline solution. To examine the safety and efficacy of urea-prostaglandin compared with the instillation of saline solution, we analyzed data from a prospective multicenter study conducted in the United States between 1975 and 1978. Both agents were highly effective in producing an abortion. However, urea-prostaglandin had a significantly lower rate of serious complications when compared with saline solution (1.03 versus 2.18 per 100 abortions; p less than 0.001). Urea-prostaglandin also had a significantly shorter induction-to-abortion time (14.2 versus 25.6 hours; p less than 0.001). Urea-prostaglandin, therefore, appears to be superior to hypertonic saline solution as an abortifacient.

We investigated perinatal and maternal deaths occurring among women who were members of a religious group in Indiana; these women received no prenatal care and gave birth at home without trained attendants. Members of the religious group had a perinatal mortality rate three times higher and a maternal mortality rate about 100 times higher than the statewide rates. These findings suggest that, even in the United States, women who avoid obstetric care have a greatly increased risk of perinatal and maternal death.All reported perinatal and maternal deaths from 1975 to 1982 among Faith Assembly members living in the state of Indiana were verified. Fetal death and the neonatal mortality rate were defined per 1000 live births; perinatal mortality was the combination of fetal deaths and neonatal deaths per 1000 births plus fetal deaths; and maternal mortality was calculated per 100.000 live births. 344 live births were identified in Elkhart and Kosciusko Counties among religious members during this period. 291 of these mothers (85%) did not have prenatal care, the prenatal care for the remaining 53 (15%) was unspecified. The mothers tended to be aged 20-34, white, married, and have minimum of high school education. 21 perinatal deaths were established among this population sample with 12 fetal deaths and 9 neonatal deaths. 11 fetal and 6 neonatal deaths occurred to members residing in the above 2 counties. Trauma or asphyxia at birth (often as a result of umbilical cord problems) and respiratory problems were responsible for most of the mortality. 6 maternal deaths occurred: 4 due to hemorrhage and 2 caused by infection. During this period there was a total of 61 maternal deaths in Indiana, and thus about 9% of maternal mortality occurred among Faith Assembly members (100% vs. 36% deaths caused by hemorrhage and infection). 3 of the 6 church members who died were 35 or older, and 2% of the births occurred to women 35 or older in these countries. The estimated perinatal mortality rate for this group was 45/1000 live births vs. 18/1000 for the whole state, almost 3 time higher. The fetal mortality rate was 32 vs. 9 for Indiana (significantly higher); and the neonatal mortality rate was 17 vs. 9, respectively. The maternal mortality rate was 872/100.000 live births for church members residing in the 2 counties vs. 9/100.000 for Indiana: an astounding ninety-twofold higher rate. The risk of perinatal and maternal death is greatly augmented even in the US when women do not utilize obstetric care.

Prompted by the continuing controversy over routine circumcision of the newborn infant, this review of the limited available literature suggests that the operation may facilitate hygiene of the penis and perhaps decrease the risk of carcinoma of the penis. On the other hand, the operation frequently features illogical bases for patient selection, neglect of the requirement to obtain informed consent, an inappropriate operator, a needlessly radical technique, disregard for pain, dubious objectives, and unknown cost-effectiveness. Long-term prospective studies are needed to evaluate routine circumcision of the newborn infant. However, until the benefits of the procedure can be proved worth the risk and cost, medical resources should probably be allocated to health measures of demonstrated value.

In light of the knowledge of the association between oxytocin administration and uterine rupture in late pregnancy, supraphysiologic doses of intravenous oxytocin are used by physicians to augment second trimester saline-induced abortions. According to the Center for Disease Control, this practice causing uterine rupturing is not unique to higher parities and can be fatal if not recognized. 2 case studies are reported. The 1st case, a 23-year-old woman (gravida 3, para 2), underwent saline instilled elective abortion at 18 menstrual weeks' gestation. Following removal of 200 cc of clear amniotic fluid from the uterus, an equal volume of 20% saline was instilled. 2 hours later, intravenous oxytocin was begun and an additional 400 mg of oxytocin was administered in the next 32 hours. 35 hours after instillation the patient had a thready pulse and blood pressure of 88/60, followed by stupor and cardiopulmonary arrest. After resuscitation a laparotomy disclosed an anterior paramedian laceration of the uterus. A hysterectomy was performed, the subsequent course was complicated, and the patient died on the 5th hospital day. In Case 2 a 29-year-old obese women (gravida 4, para 3) had an elective saline-instilled abortion at 20 menstrual weeks' gestation. After saline instillation the patient received intravenous oxytocin in the following amounts: 1) 60 mg; 2) 40 mg, with mild bleeding noted, and 3) 60 mg, followed by profuse vaginal bleeding. The fetus and the placenta were removed, and no detection of uterine rupture was made. The patient was transferred to another hospital, and died 5 hours later following multiple cardiopulmonary arrests. Rupture of the gravida uterus is defined as disruption of the uterine wall, occurring predominantly in the lower uterine segment. Uterine rupture and rupture during a term birth are probably analogous. The death-to-case rate for saline-induced abortions in the U.S. from 1972 to 1975 is .08 deaths/100,000, however, this rate would be higher if only saline-induced abortions receiving oxytocin were considered.

To compare the safety and feasibility of midtrimester abortion by outpatient dilatation and evacuation (D-E) versus inpatient intra-amniotic instillation of prostaglandin F2 alpha (PGF2 alpha), we performed a randomized clinical trial with 100 subjects estimated to be 13 to 18 menstrual weeks pregnant. Subjects undergoing D-E abortion had significantly better compliance with the assigned treatment (100% vs. 88%,0.05) and less delay prior to abortion (mean 3.7 vs. 10.1 days, p0.001). Subjects receiving PGF2 alpha had a relative risk of sustaining a complication 5.7 times that of subjects undergoing D-E (95% confidence interval 2.1-15.3, p0.001). Subjects receiving PGF 2 alpha also had significantly higher rates of vomiting and diarrhea (p0.01). Midtrimester abortion by outpatient D-E appears to be more acceptable to women, faster, and safer than by instillation of PGF2 alpha.100 subjects comprised a randomized clinical trial to compare the safety and feasibility of 2 methods of midtrimester abortion. Outpatient (D-E) dilatation and evacuation and inpatient intraamniotic instillation of (PGF2alpha) prostaglandin F2alpha were the 2 methods utilized on these subjects estimated to be 13-18 weeks pregnant. Subjects undergoing D-E abortion had significantly better compliance with the assigned treatment (100% vs. 88%, P 0.05) and less delay prior to abortion (mean 3.7 vs 10.1 days P 0.001). Subjects receiving the PGF2alpha had a relative risk or sustaining complications 5.7 times that of subjects undergoing the other procedure (95% confidence interval 2.1-15.3, P 0.001). The subjects receiving the PGF2 alpha also had significantly higher rates of vomiting and diarrhea (P 0.01). Midtrimester abortion by outpatient D-E is proven faster, safer, and more acceptable to women than PGF2 alpha instillation.

The randomized clinical trial is one of the major achievements of our times. Randomized trials set the standard for scientific rigor. They are medicine's closest approximation to the controlled experiments of the laboratory scientist. These studies prevent selection bias and minimize ascertainment bias. In addition, they are statistically efficient. There have been few randomized clinical trials comparing the metabolic effects and adverse drug experiences of low-dose oral contraceptives. Previous studies conducted with oral contraceptives containing higher doses of estrogen (equivalent to greater than 50 micrograms of ethinyl estradiol) may not be relevant today when low-dose preparations are more widely used. For this reason a randomized trial was conducted to compare three multiphasic oral contraceptives marketed in the United States.