Complications of first-trimester abortion by vacuum aspiration after cervical preparation with and without misoprostol: a multicentre randomised trial.

Background: Little information is available about the incidence of complications from vacuum aspiration for first-trimester abortion after cervical preparation with prostaglandin analogues. We compared incidence of complications from vacuum aspiration in women who had had cervical preparation with misoprostol and those who had not.

Methods: We did a randomised parallel-group trial at 14 centres in nine countries between Oct 22, 2002, and Sept 24, 2005.

Effect on pregnancy rates of the delay in the administration of levonorgestrel for emergency contraception: a combined analysis of four WHO trials.

Background: Levonorgestrel is an effective method for emergency contraception (EC) and is used worldwide. Consistent with its mechanism of action in delaying ovulation, the earlier it is administered within 72 h of an unprotected act of intercourse, the more effective it is. There is uncertainty, however, about its effectiveness after 72 h.

A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.

Background: Unplanned pregnancies are common in Nigeria. Much of the unplanned pregnancies is due to low contraceptive prevalence and high contraceptive user failure rates. High user failure rates suggest the important role of emergency contraception to prevent unplanned pregnancy.

Gestrinone compared with mifepristone for emergency contraception: a randomized controlled trial.

Objective: To compare the efficacy of gestrinone with that of mifepristone for emergency contraception.

Methods: A randomized double-blind trial was conducted in five family-planning clinics in China. We randomly assigned 998 healthy women with regular menstrual cycles and negative urine pregnancy tests who were requesting emergency contraception up to 72 hours after unprotected coitus to receive single-dose 10 mg gestrinone (n=499) or 10 mg mifepristone (n=499).

Emergency contraception: the state of the art.

Emergency contraception, otherwise known as post-coital contraception, is part of the continuum of contraceptive methods that women and couples can use for pregnancy prevention. Although emergency contraception should not be used as a regular, plan-ahead contraceptive method, it gives a woman one last-ditch effort to prevent unwanted pregnancy. This paper reviews the history of emergency contraception, the need for further studies, and results of studies conducted at the World Health Organization.

Comparison of vaginal and sublingual misoprostol for second trimester abortion: randomized controlled equivalence trial.

Background: To identify an effective misoprostol-only regimen for the termination of second trimester pregnancy, we compared sublingual and vaginal administration of multiple doses of misoprostol in a randomized, placebo-controlled equivalence trial.

Methods: Six hundred and eighty-one healthy pregnant women requesting medical abortion at 13-20 weeks' gestation were randomly assigned within 11 gynaecological centres in seven countries into two treatment groups: 400 microg of misoprostol administered either sublingually or vaginally every 3 h up to five doses, followed by sublingual administration of 400 microg misoprostol every 3 h up to five doses if abortion had not occurred at 24 h after the start of treatment. We chose 10% as the margin of equivalence.

Comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination.

Background: It is not known whether a 400 microg dose of misoprostol has a similar efficacy as an 800 microg dose when administered sublingually or vaginally 24 hours after 200 mg mifepristone.

Methods: It is proposed to undertake a placebo-controlled, randomized, non-inferiority trial (3% margin of equivalence) of the two misoprostol doses when administered sublingually or vaginally using factorial design. A total of 3008 pregnant women (< 63 days of gestational age) who request legal termination of pregnancy will be recruited for the trial at 16 clinics in ten countries providing abortion services.

Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial.

Background: The most effective route and best interval between several doses of misoprostol to induce abortion have not been defined. Our aim was to assess the effects of the interval between multiple doses of misoprostol and the route of administration to terminate pregnancy.

Methods: 2066 healthy pregnant women requesting medical abortion with 63 days or less of gestation were randomly assigned within 11 gynaecological centres in six countries to the four treatment groups (three doses of 0.

Pharmacokinetics of a single oral dose of 1.5-mg levonorgestrel when administered as 750-mug tablets or as 30-microg minipills.

We examined the pharmacokinetics of a single dose of 1.5 mg of levonorgestrel when administered orally in two different formulations: two tablets of 0.75 mg or 50 minipills of 30 microg of levonorgestrel.

Frequently asked questions about medical abortion.

The development of methods of inducing abortion medically (nonsurgically) has created alternative options to make abortion available to women in a variety of health-care settings. Medical abortion is induced with a regimen of mifepristone followed by a prostaglandin analogue. Since its first introduction in the late 1980s, the regimen has undergone some modifications based on research evidence, and, in many countries, clinicians are using regimens that may differ from the one that has been licensed.

Pharmacokinetics and endometrial tissue levels of levonorgestrel after administration of a single 1.5-mg dose by the oral and vaginal route.

Objective: To determine the pharmacokinetics and endometrial tissue levels of levonorgestrel when taken as a single dose of 1.5 mg either orally or vaginally by healthy women in the periovulatory phase of their menstrual cycle.

Design: Prospective randomized study.

Late follicular phase administration of mifepristone suppresses circulating leptin and FSH - mechanism(s) of action in emergency contraception?

Objective: Low dose mifepristone (RU486) is highly effective in emergency post-coital contraception (EC), although the mechanism(s) of action remains unclear. We studied the endocrine actions of 10 mg mifepristone administered orally as a single dose to eight healthy volunteers (aged 20-45 years) during the late follicular phase.

Methods: Serum levels of LH, FSH, oestradiol, progesterone, leptin, mifepristone, cortisol, and gluco-corticoid bioactivity (GBA) were measured before and 1, 2, 4 and 8 h after ingestion of mifepristone on cycle day 10 or 11 (study day 1), and follow-up was continued for 10 days.

Antiprogestins for contraception?

Antiprogestins could be a very promising group of compounds for contraception because they counteract the effects of progesterone, a key hormone for normal reproductive functioning. Great efforts have therefore been devoted to testing various ways of using these compounds for family planning. Most of this work has involved mifepristone; other antiprogestins have not been available for trials.

Tolerability of levonorgestrel emergency contraception in adolescents.

Objective: We evaluated the tolerability of emergency contraception in adolescents. Study design In this descriptive study, 1 0.75 mg levonorgestrel tablet was administered to 52 females aged 13-16 with instructions to take the second tablet 12 hours later (unprotected intercourse was not an entry requirement).

Menstrual induction with mifepristone and misoprostol.

Menstrual induction refers to early uterine evacuation without laboratory confirmation of pregnancy in women with delayed menses. Mechanical aspiration is the method used in many countries but, as suggested by a pilot study, mifepristone followed by a prostaglandin analogue could also be effective. We launched the present study to evaluate the efficacy and side effects of 150 mg of mifepristone, followed 2 days later by 0.

Luteal phase treatment with mifepristone and misoprostol for fertility regulation.

Emergency contraception (EC) with 10 mg mifepristone can prevent pregnancy up to 5 days after a single act of unprotected intercourse. No methods have been shown to be effective when treatment is administered more than 5 days after a single unprotected act or after several unprotected acts. Therefore, we tested, among 699 Chinese women requesting EC and exposed to the risk of pregnancy described, the potential of 100 mg mifepristone followed 2 days later by 0.

Meta-analyses of randomized trials comparing different doses of mifepristone in emergency contraception.

There is some evidence from randomized trials that different doses of mifepristone for emergency contraception do not differ in efficacy in the range from 10 mg to 600 mg. Lower doses have a better side effect profile and are cheaper and therefore they would be preferable in the absence of a dose effect. However, the lack of significance is not evidence of absence of an effect.

Combined estimates of effectiveness of mifepristone 10 mg in emergency contraception.

The present paper combines the estimates of efficacy and side effects of 10 mg mifepristone for emergency contraception obtained from randomized trials. A total of 6083 women participating in 12 randomized trials and receiving 10 mg mifepristone for emergency contraception up to 120 h after intercourse, were analyzed for efficacy. Between 4188 and 5833 women were analyzed for side effects and 3601 for delay of menses of more than 7 days.

Expanded clinical trial of emergency contraception with 10 mg mifepristone.

We conducted a clinical single-arm trial to evaluate the effectiveness of 10 mg mifepristone for emergency contraception (EC) in a large population in China. The participating centers were 31 family-planning clinics and hospitals in the following 19 provinces or municipalities in China: Beijing, Shanghai, Tianjin, Harbin, Changchun, Shengyang, Shijiazhuang, Zhengzhou, Taiyuan, Nanjing, Jinan, Hangzhou, Guangzhou, Wuhan, Changsha, Chongqing, Guiyang, Chengdu, Kunming. A total of 4945 women requesting EC within 120 h after a single act of unprotected intercourse were recruited and treated with 10 mg mifepristone.

Pharmacokinetics of 10 mg of mifepristone.

The results of several randomized studies have verified the efficacy of 10 mg mifepristone in emergency contraception. In the present study we characterized the pharmacokinetics of 10 mg mifepristone. Eight healthy female volunteers received a single oral dose of mifepristone on the day 10 or 11 of their menstrual cycle.

Levonorgestrel and mifepristone in emergency contraception.

Research on new technologies by the Special Programme of Research, Development and Research Training in Human Reproduction at WHO has led to the development of two new methods for emergency contraception, the levonorgestrel regimen and a low-dose mifepristone regimen. In 4 years, the levonorgestrel regimen has already been approved in some 95 countries. We review this research and present combined data from our multinational trials and combined estimates of efficacy for mifepristone and for levonorgestrel separately.

Synergistic effects of antiprogestins and iNOS or aromatase inhibitors on establishment and maintenance of pregnancy.

Progesterone is known to be involved in many steps in female reproduction including control of implantation and uterine-cervical function during pregnancy. Our studies in rats and guinea pigs indicate that progesterone inhibits uterine contractility and cervical softening during pregnancy. Progesterone levels or actions decline near the end of pregnancy leading to the onset of labor.