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Objective: We conducted a systematic review of the literature on the effectiveness of medical abortion “reversal” treatment. Since the usual care for women seeking to continue pregnancies after ingesting mifepristone is expectant management with fetal surveillance, we also performed a systematic review of continuing pregnancy after mifepristone alone. Study design: We searched PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus and the Cochrane Library for articles published through March 2015 reporting the proportion of pregnancies continuing after treatment with either mifepristone alone or after an additional treatment following mifepristone aimed at reversing its effect. Results: From 1115 articles retrieved, 1 study met inclusion criteria for abortion reversal, and 13 studies met criteria for continuing pregnancy after mifepristone alone. The one report of abortion reversal was a case series of 7 patients receiving varying doses of progesterone in oil intramuscularly or micronized progesterone orally or vaginally; 1 patient was lost to follow-up. The study was of poor quality and lacked clear information on patient selection. Four of six women continued the pregnancy to term [67%, 95% confidence interval (CI) 30– 90%]. Assuming the lost patient aborted resulted in a continuing pregnancy proportion of 57% (95% CI 25–84%). The proportion of pregnancies continuing 1–2 weeks after mifepristone alone varied from 8% (95% CI 3–22%) to 46% (95% CI 37–56%). Continuing pregnancy was more common with lower mifepristone doses and advanced gestational age. Conclusions: In the rare case that a woman changes her mind after starting medical abortion, evidence is insufficient to determine whether treatment with progesterone after mifepristone results in a higher proportion of continuing pregnancies compared to expectant management. Implications: Legislation requiring physicians to inform patients about abortion reversal transforms an unproven therapy into law and represents legislative interference in the patient–physician relationship. © 2015 Elsevier Inc. All rights reserved.

Beginning in the 1960s depot medroxyprogesterone acetate (DMPA) injectable contraception has been widely used in family planning programs abroad especially in Africa and Southeast Asia [1]. Approved in the US for the treatment of endometrial cancer in the mid-1960s it was also used off-label for contraception [2]. In 1992 DMPA received Food and Drug Administration (FDA) approval for contraception and began to have a noticeable impact in preventing unintended pregnancies in the US particularly among teens. By 2002 some 2 million US women used injectable contraception [3]. Whereas US teen births increased 23% from 1986 peaking in 1991 rates then declined 35% by 2005 [4]. The authors of the 2002 National Survey of Family Growth (NSFG) reported that “Teens were more likely in 2002 to use contraception at first sex and at most recent sex than in 1995 and were more likely to have used highly effective methods such as injectable contraception” [5]. Copyright © 2014 Elsevier Inc. All rights reserved.

Feticidal injection of digoxin before dilation and Level II studies have a control group and thus allow evacuation (D&E) abortion has become common in recent years and is now a standard policy at some abortion clinics. The procedure entails amniocentesis and administration of digoxin into the amniotic fluid or fetus before uterine evacuation. Two new reports in this issue of the journal present conflicting views about its safety [1,2]. An invasive procedure, amniocentesis causes pain and incurs cost, inconvenience and risk. Hence, clear justification is needed for it to be used routinely. Several rationales, discussed below, have been invoked for digoxin injection before D&E.

Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects.We searched electronic databases for studies of Sino-implant (II) and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy.Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the 4 years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for 4-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for 4 years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II).Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings.

Background: Theories and models help explain how behavior change occurs. We systematically reviewed randomized controlled trials that examined theory-based interventions for improving contraceptive use. Study Design: We searched electronic databases for eligible trials. Primary outcomes included pregnancy and contraceptive use. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. Results: Of 14 included trials, 10 showed positive results for a theory-based group: 2 of 10 studies with pregnancy or birth data, 4 of 9 addressing contraceptive use (for contraception) and 5 of 9 with condom use (to prevent HIV/sexually transmitted infections). An experimental group had favorable results for six of seven trials based on Social Cognitive Theory, two based on other social cognition models and two using motivational interviewing. Most interventions focused on adolescents and involved multiple sessions. Conclusions: Effects were not consistent across outcomes and comparisons. The field could benefit from thorough use of single theories and better reporting on intervention implementation.

In countries where levonorgestrel-releasing IUD use has increased the incidence of female surgical sterilization procedures has decreased. Will the same inverse relationship appear in the United States and if so what would be the medical implications of such a transition in long-term contraception? A recent UK review compared long-term contraception with IUDs vs. surgical sterilization; here we compare these two approaches from a US perspective. We focus on interval tubal sterilization by laparoscopy or laparotomy and will not consider postpartum sterilization. (excerpt)

The Fertility Regulation Group of the Cochrane Collaboration has been assessing the best available evidence on fertility regulation, family size and birth spacing. By the end of 2005, this group had published 32 systematic reviews and 12 protocols; most reviews were on contraception. Because of suboptimal trial quality, firm conclusions could be made in only five reviews. Threats to internal validity in published trials include the absence of description of allocation concealment, intentional exclusion of participants after randomization, failure to use intention-to-treat analyses and lack of treatment blinding. The precision of results has been limited by small sample sizes. The finding that most trials of oral contraceptives were conducted by pharmaceutical companies raises concerns about potential commercial bias. Of necessity, most information about fertility regulation effectiveness and adverse effects comes from observational studies, which vary widely in quality. Systematic reviews of evidence, with an emphasis on randomized controlled trials when available, will continue to improve fertility regulation in the years ahead.

Concern about estrogen-related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). This review of randomized controlled trials tested the hypothesis that COCs containingor=20 microg ethinyl estradiol (EE) perform similarly to those containing20 microg in terms of contraceptive effectiveness, bleeding patterns, discontinuation and side effects. Data from the 18 eligible trials conducted to date are inadequate for detecting possible differences in contraceptive effectiveness. Several COCs containing 20 microg EE resulted in higher rates of early trial discontinuation (overall and due to adverse events such as irregular bleeding) as well as increased risk of bleeding disturbances (both amenorrhea/infrequent bleeding and irregular, prolonged, frequent bleeding or breakthrough bleeding or spotting) than their higher-estrogen comparison pills. However, most trials compared COCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose. While health care providers and women might select COCs containing 20 microg EE based on theoretical improvements in safety profile from the reduced dose of estrogen, no evidence is available to support this choice.

Contraception choices may be limited for lactating women due to concerns about hormonal effects on quality and quantity of milk, passage of hormones to the infant and infant growth. We conducted a systematic review of randomized controlled trials to determine the effect of hormonal contraception on lactation. We sought all randomized controlled trials, reported in any language, that included any form of hormonal contraception compared with another form of hormonal contraception, nonhormonal contraception or placebo during lactation. Seven reports from five randomized controlled trials met the inclusion criteria. Most of the five trials did not specify their method used to generate a random sequence, method of allocation concealment, blinding of treatments or use of an intention-to-treat analysis. Additionally, high loss-to-follow-up rates invalidated at least two trials. The findings from two trials comparing oral contraceptives to placebo during lactation were conflicting. Another trial found no inhibitory effects on lactation from progestin-only contraceptives. Finally, the World Health Organization trial found a statistically significant decline in breast milk volume in women using combined oral contraceptives compared to women using progestin-only pills. However, infant growth for the two groups did not differ. The limited evidence from randomized controlled trials on the effect of hormonal contraceptives during lactation is of poor quality and insufficient to establish an effect of hormonal contraception, if any, on milk quality and quantity. At least one properly conducted randomized controlled trial of adequate size is urgently needed to make recommendations regarding hormonal contraceptive use for lactating women.

The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and it does not require fitting or a prescription from a physician. We conducted a systematic review of randomized controlled trials that compared the vaginal contraceptive sponge with the diaphragm used with a spermicide in order to evaluate the efficacy and continuation rates of the two devices. The sponge was statistically significantly less effective in preventing overall pregnancy than was the diaphragm in the two trials that met our inclusion criteria. The 12-month cumulative life table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger US trial, and 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm [odds ratio 1.3; 95% confidence interval (CI) 1.1-1.6]. Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two trials. Other randomized controlled trials will be needed to resolve the role of spermicides in preventing sexually transmitted infections or in causing adverse effects.

From 4%-14% of intrauterine device (IUD) users have their IUD removed due to bleeding or pelvic pain in the first year of use. Past studies have analyzed whether baseline patient information can help predict such removals, but no previous analysis has examined whether information provided at the recommended 1-month follow-up visit could improve such predictions. Using data from an international multicenter randomized controlled trial, 89 women with removals for bleeding and pain after the 1-month visit were compared with 2536 continuing users. Logistic regression indicated several significant predictors of removal. Women reporting intermenstrual bleeding since last menses were nearly three times more likely to have removals for bleeding or pain (odds ratio [OR] 2.9; 95% confidence interval [CI] 1.4-5.9). Similarly, those complaining of excessive menstrual flow were 3.5 times more likely to have removals within 12 months (95% CI 1.4-9.2). Women reporting these menstrual problems during scheduled revisits may benefit from counseling and treatment with nonsteroidal anti-inflammatory drugs (NSAID).

The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study ( RR = 0.81; 95% CI 0.28–2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group. These retention rates indicate that US women can exhibit a high degree of user acceptance.

This commentary explains why the Food and Drug Administration (FDA) should remove the black box warning regarding skeletal health on the package labeling for the injectable contraceptive depot medroxyprogesterone acetate (DMPA). It states that by depriving women of long-term use of this safe effective product this black box warning hurts the public health. Copyright © 2011 Elsevier Inc. All rights reserved.

Side effects of combined oral contraceptives are the most common reason why women discontinue them. Over the past half century, an elaborate mythology about these ill effects has evolved, fueled by rumor, gossip and poor-quality research. In contrast, placebo-controlled randomized trials document that nonspecific side effects are not significantly more common with combined oral contraceptives than with inert pills. These reported nonspecific side effects may reflect the nocebo phenomenon (the inverse of a placebo): if women are told to expect noxious side effects, these complaints occur because of the power of suggestion. Alternatively, nonspecific complaints may simply reflect their background prevalence in the population. Because Level I evidence documents no important increase in nonspecific side effects with oral contraceptives, counseling about these side effects or including them in package labeling is unwarranted and probably unethical. When in doubt, clinicians should err on the side of optimism.

The term "forgettable contraception" has received less attention in family planning than has "long-acting reversible contraception." Defined here as a method requiring attention no more often than every 3 years, forgettable contraception includes sterilization (female or male), intrauterine devices, and implants. Five principal factors determine contraceptive effectiveness: efficacy, compliance, continuation, fecundity, and the timing of coitus. Of these, compliance and continuation dominate; the key determinants of contraceptive effectiveness are human, not pharmacological. Human nature undermines methods with high theoretical efficacy, such as oral contraceptives and injectable contraceptives. By obviating the need to think about contraception for long intervals, forgettable contraception can help overcome our human fallibility. As a result, all forgettable contraception methods provide first-tier effectiveness (/=2 pregnancies per 100 women per year) in typical use. Stated alternatively, the only class of contraceptives today with exclusively first-tier effectiveness is the one that can be started -- and then forgotten for years.

Studies on family planning methods traditionally have relied on self-reports of unknown validity and reproducibility. Social desirability bias, a type of information bias, occurs when study participants respond inaccurately - but in ways that will be viewed favorably by others. Several lines of evidence reveal that this bias can be powerful in sexual matters, including reports of coitus, use of contraceptives and induced abortion. For example, studies using vaginal prostate-specific antigen testing reveal underreporting of unprotected coitus and overreporting of barrier contraceptive use. Medication Event Monitoring System studies, which electronically record the time of pill dispensing from a bottle or pack, indicate widespread exaggeration of adherence to pill-taking regimens, including oral contraceptives. Comparisons of provider data and self-reports of induced abortions reveal extensive underreporting of induced abortion. Reliance on self-reported data underestimates contraceptive efficacy. Although techniques to minimize this bias exist, they are infrequently used in family planning studies. Greater skepticism about self-reports and more objective means of documenting coitus and contraceptive use are needed if contraceptive efficacy is to be accurately measured.

Background The appropriateness of IUDs for adolescents remains unsettled, as does the definition of the term adolescent. Unplanned pregnancy among teenagers remains epidemic, and long-acting methods, such as IUDs, offer the promise of top-tier effectiveness. Study Design We conducted a systematic review of the literature concerning IUD use in adolescents using MEDLINE, Popline, EMBASE and CINAHL databases. Results Six cohort studies and seven case-series reports met our inclusion criteria; none included IUDs in current use in the United States. Overall, continuation rates were high and cumulative pregnancy rates low, ranging from 2% at 6 months to 11% at 48 months. Compared with combined oral contraceptives, IUDs had similar or better continuation rates; pregnancy rates were similar at 2 years. IUD expulsion rates may be inversely related to age. Conclusions The literature on IUD use among adolescents is scanty and obsolete. Nevertheless, published reports were generally reassuring. Randomized controlled trials and cohort studies comparing contemporary IUDs with other methods are urgently needed.

Several recent reports have suggested that sex hormone-binding globulin (SHBG) might be a surrogate marker for venous thromboembolism (VTE) during combined oral contraceptive (COC) use. Uncritical acceptance of invalid surrogate markers threatens patient health and has caused thousands of preventable deaths in recent decades. Hence clinicians have an ethical obligation to validate any proposed surrogate end point. The authors examine the hypothesis that this globulin is a surrogate marker for VTE in oral contraceptive users considering both laboratory medicine and epidemiology. The authors conclude no valid surrogate marker for VTE exists for women using COCs. The best available evidence suggests that all contemporary COCs in Europe are associated with a similar risk of VTE. Hence putative surrogate markers for VTE cannot distinguish between different types of COCs.

Background Intrauterine devices (IUDs) are the most widely used reversible contraceptives in the world today, and decisions about their use should reflect the best available evidence. Study Design We performed a computer search of the Cochrane Library for all IUD-related reviews. Results Eleven reviews related to IUDs have been registered in The Cochrane Library; 10 have been completed, and one is in progress. Topics include type of IUD, timing of insertion, clinical management, emergency contraception and use as gynecological treatment. The copper T380A is the most effective copper IUD; the levonorgestrel intrauterine system has efficacy comparable to that of IUDs with >250 mm 2 of copper. The frameless device may be comparable in efficacy to the copper T380A, although whether problems with the initial inserter are resolved is unclear. Immediate postpartum and postabortal insertion appears safe and effective, although trials comparing immediate to delayed insertions are scarce. Prophylactic antibiotics at the time of insertion appear unwarranted except in populations with a high prevalence of sexually transmitted diseases. Many nonsteroidal anti-inflammatory drugs reduce pain and bleeding associated with IUDs, although prophylactic use of ibuprofen does not improve continuation rates. The levonorgestrel system is superior to oral progestins in treating heavy uterine bleeding. This IUD compares favorably with endometrial ablation techniques and presents an alternative to hysterectomy for many women. Discussion Trials are needed to evaluate immediate vs. delayed insertion after delivery or abortion and to explore emerging therapeutic uses of the levonorgestrel system, such as treatment of endometrial hyperplasia.

Context: Fertility awareness-based (FAB) methods of family planning estimate the fertile days of the menstrual cycle whether by observing fertility signs such as cervical secretions and basal body temperature or by monitoring cycle days. The efficacy and acceptability of these methods are unclear. Methods: We retrieved and analyzed all randomized controlled trials that examined any FAB method used for contraception. Results: Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods, but a trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two American trials, recruitment of participants was unexpectedly difficult. Continuation rates were poor. Conclusion: Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. The comparative efficacy of these methods remains unknown. However, with the ovulation and symptothermal methods, pregnancies appear to be common; method continuation rates are low.

Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so an “add-back” therapy is needed. We conducted a systematic review of all randomized controlled trials of male hormonal contraception and azoospermia. Few significant differences emerged from these trials. Levonorgestrel implants combined with injectable testosterone enanthate (100 mg im) were significantly more effective than was levonorgestrel 125 μg po daily combined with testosterone patches [10 mg/d; odds ratio (OR) for azoospermia with the oral levonorgestrel regimen, 0.03; 95% CI, 0.00–0.29]. The addition of levonorgestrel 500 μg po daily improved the effectiveness of testosterone enanthate 100 mg im weekly by itself (OR for azoospermia with the combined regimen, 4.0; 95% CI, 1.00–15.99). Several regimens, including testosterone alone and gonadotropin-releasing hormone agonists and antagonists, had disappointing results. In conclusion, no male hormonal contraceptive is ready for clinical use. All trials published to date have been small exploratory studies. As a result, their power to detect important differences has been limited and their results have been imprecise. In addition, the definition of oligospermia has been imprecise or inconsistent in many reports. To avoid bias, future trials need to pay more attention on the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful.

Side effects caused by oral contraceptives discourage compliance with and continuation of oral contraceptives. A suggested disadvantage of biphasic oral contraceptive pills compared to triphasic oral contraceptive pills is an increase in breakthrough bleeding. We examined this potential disadvantage by conducting a systematic review comparing biphasic oral contraceptives with triphasic oral contraceptives in terms of efficacy, cycle control, and discontinuation because of side effects. We included randomized, controlled trials comparing any biphasic oral contraceptive with any triphasic oral contraceptive when used to prevent pregnancy. Only two trials of limited quality met our inclusion criteria. Larranaga compared two biphasic and one triphasic pills, each containing levonorgestrel and ethinyl estradiol. No important differences emerged, and the frequency of discontinuation because of medical problems was similar with all three pills. Percival-Smith compared a biphasic pill containing norethindrone (Ortho 10/11) with a triphasic pill containing levonorgestrel (Triphasil) and another triphasic pill containing norethindrone (Ortho 7/7/7). The biphasic pill had inferior cycle control compared with the levonorgestrel triphasic pill. The available evidence is limited and of poor quality; the internal validity of these trials is questionable. Given that caveat, the biphasic pill containing norethindrone was associated with inferior cycle control compared with the triphasic pill containing levonorgestrel. This suggests that the choice of progestin may be more important that the phasic regimen in determining bleeding patterns.

Compliance difficulties are more common among oral contraceptive (OC) users than generally appreciated by clinicians, in part because unintended pregnancy is a relatively infrequent consequence and in part because more common manifestations such as spotting and bleeding may not be recognized as resulting from poor compliance. While improving compliance is a shared responsibility of patients, clinicians, and manufacturers, the clinician is the focal point for these efforts. Counseling must be individualized, which requires knowledge of factors that predict compliance and an understanding of the patient's decision-making process as it relates to medications. Most OC compliance research has focused on adolescents, where predictors of poor compliance include multiple sex partners, low evaluation of personal health, degree of concern about pregnancy, and previous abortion. Good compliance has been linked with patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.The findings of decades of research on user compliance of drug treatment regimens can be reduced to a simple statement that a third of users always comply, a third never complies, and a third sometimes complies. The efficacy of oral contraceptives (OC), however, relies on compliance even though poor compliance has no immediate or uniform consequences. Research on OC compliance has focused on adolescents because of their high pregnancy rates and their high reliance on OCs. Young women frequently use OCs in a sporadic fashion. While most adolescents are as compliant as older women, only 26% of those aged 14 and younger take their OC daily as compared to 40% of all other age groups. Attempts have been made to identify factors predicting noncompliance using 1) the individualistic model, which measures a number of factors using statistical techniques; 2) the health belief model which postulates that health-seeking behavior depends upon perception of health risk, and 3) the patient-provider model which highlights the importance of communication techniques. Factors which have been found to influence OC use are the occurrence of side effects, the routine followed, and failure to read and/or understand the packaging information. Little is known about the influence of patient-provider interactions, and only a few strategies to improve compliance have been studied. To improve compliance, health care providers should properly counsel women on their choice of method, side effects, OC misinformation and beneficial effects, correct use, missed pill instructions, and how to get additional information. Proper follow-up techniques should also be used. OC users can improve compliance by following a regular routine, carefully reading packaging information, knowing what to do if an OC is missed, and identifying a back-up method. Manufacturers should encourage research into compliance predictors and factors, incorporate findings into tools to help clinicians identify those at risk, use packaging that encourages compliance, and develop standardized and comprehensible written materials.

Mifepristone (RU486) should be useful for inducing menstrual bleeding in women with menses delayed up to 10 days. We evaluated this potential use for "menstrual regulation" in a randomized clinical trial with 16 women, half of whom received a single 600 mg dose and half of whom received a placebo. Four of eight women in each treatment group proved to be pregnant. Seven of eight who received mifepristone were not pregnant at two-week follow-up, in contrast to four of eight who received the placebo (p = 0.15). Mifepristone may hold promise for "menstrual regulation" for women who do not have access to medical confirmation of pregnancy or who choose not to have this determination made.Physicians in southern California conducted a double blind, randomized clinical trial (single oral 600 mg dose of RU-486 given to 8 women and a placebo to 8 other women) to determine its effectiveness in inducing delayed menstrual bleeding (i.e., menstrual regulation) and its acceptability. 4 women in each group were actually pregnant. 75% of the pregnant women in the RU-486 group experienced an abortion within 2 weeks while none of the pregnant women in the placebo group did. In other words, 88% of the RU-486 group were not pregnant 2 weeks after treatment compared with 50% of those in the placebo group (p=0.15). 1 woman in the placebo group whose initial beta human chorionic gonadotropin (hCG) level was 658 mIU/ml had a miscarriage later in the 1st trimester. Another woman in the RU-486 group, the only person enrolled twice in the study, experienced an abortion when her beta hCG level was 360 mIU/ml. The 2nd time her beta hCG level was 104 mIU/ml, however, and she did not experience an abortion. 2 of the nonpregnant women who received RU-486 started bleeding. The other 2 women had most likely not ovulated when they took RU-486. Side effects were similar for both groups, except for a more significant fall in hematocrit levels in the placebo group (p=0.03). 93.8% of all study subjects regardless of abortion or not thought RU-486 to be efficacious and preferred it to a surgical abortion even before they knew whether they would receive RU-486 or the placebo. 88.9% of the subjects who reported their feelings about abortion 4 weeks following treatment or the placebo claimed emotional relief on day 1. All expressed relief 2-4 weeks afterwards. RU-486 can be successfully used to regulate menstruation, especially in populations without access to medical are and pregnancy tests, and it may appeal to women who prefer not to know their status.

The potential relationship between use of intrauterine devices and pelvic inflammatory disease is one of the most important issues in contraception today. A number of large, sophisticated studies published since mid-1980 have clarified this association. All have consistently revealed an increased risk of pelvic inflammatory disease among intra-uterine device users, but the most objective of these studies indicate a relative risk compared to women using no method (1.5-2.6) lower than previous estimates. For most intrauterine device wearers, the increased risk of pelvic inflammatory disease persists for only a few months after insertion. The Dalkon Shield appears associated with a higher risk of pelvic inflammatory disease than the Lippes Loop, Saf-T-Coil, or copper devices. Careful selection of candidates for intrauterine devices may further reduce the risk of intrauterine device-associated pelvic inflammatory disease.The potential relationship between use of IUDs and pelvic inflammatory disease (PID) is one of the most important issues in contraception today. A number of large sophisticated studies published since mid-1980 have clarified this association. All have consistently revealed an increased risk of PID among IUD users, but the most objective of these studies indicate a relative risk compared to women using no method (1.5-2.6) lower than previous estimates. For most IUD users, the increased risk of PID persists for only a few months after insertion. The Dalkon Shield appears associated with a higher risk of PID than the Lippes Loop, Saf-T-Coil, or copper devices. Taken together, these studies suggest that IUD use carries a small but real risk of PID that is attributable to endometrial contamination at the time of insertion. Careful selection of candidates for IUD use--white women aged 25 years or over who have only 1 sexual partner--can reduce this risk.