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Meta-analyses of randomized trials comparing different doses of mifepristone in emergency contraception.
Contraception. 2003 Dec; 68(6):447-452.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. More evidence can be obtained by combining results of trials. We present meta-analyses of randomized trials comparing doses of mifepristone for emergency contraception from 5 mg to 600 mg, with regard to the efficacy to prevent unwanted pregnancies. We use two approaches for analysis, one using only within-trial information and another one combining within-trial with between-trial information. We discuss the results in terms of equivalence. There is some evidence of a small dose effect on efficacy in the lower range of doses (<50 mg). The pregnancy rate increases by a factor of 1.6 when the dose of 10 mg is used instead of 25 mg (95% confidence interval: 1.1–2.4). In terms of the number of women needed to treat, however, using 10 mg in the place of 25 mg implies having one extra pregnancy every 146 women requesting emergency contraception, which might be a low cost compared to the benefit of more women having access to treatment. (author's)
Contraception. 2003 Dec; 68(6):439-446.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. Prevented fractions, the effect of delay and of further acts of intercourse after treatment administration were analyzed in 3440 women, using individual data. The combined pregnancy rate from all the 12 trials was 1.7% [101/6083, 95% confidence interval (CI): 1.3–2.2]. From the three trials providing individual data, the combined pregnancy rate was 1.3% (45/3440, 95% CI: 0.9 –1.7) and the estimate of pregnancies prevented was 83.4% (95% CI: 77.4–87.8). There was a sharp decline in efficacy when treatment was administered during the 5th day after intercourse compared to administration during the 1st day, the odds of pregnancy increasing by a factor of 5.3 (95% CI: 1.9 –14.9). The relative risk of pregnancy was about 28 times higher among women with unprotected acts of coitus between treatment administration and the onset of next menses, compared with women reporting none [odds ratio (OR) = 27.6, 95% CI: 12.7– 60.2]. The increase in risk for women reporting protected acts of intercourse during this interval was not statistically significant (OR = 1.8, 95% CI: 0.9 –3.8). There was a large heterogeneity among trials in all side effects and delay of menses of more than 7 days (all had p < 0.0001 for the test of homogeneity). The percentage of women with nausea ranged from 0.0–19.4% (highest upper 95% confidence limit: 23.0%), that of vomiting from 0.0–4.3% (highest upper 95% confidence limit: 6.1%), that of lower abdominal pain from 4.3–19.1% (highest upper 95% confidence limit: 22.7%). The percentage of women with delay of menses of more than 7 days ranged from 4.3–25.8% (highest upper 95% confidence limit: 34.1%). We conclude that 10 mg mifepristone is an effective emergency contraception regimen, with an acceptable side-effects profile. Postponing treatment until the 5th day seriously decreases efficacy. The risk of pregnancy is dramatically increased among women having unprotected acts of intercourse between treatment administration and the onset of next menses. This risk may be enhanced for women whose ovulation is postponed by treatment. (author's)
Summary of evidence and research needs on the use of mifepristone in fertility regulation: consensus from the conference.
Contraception. 2003 Dec; 68(6):401-407.The conference on the use of mifepristone to reduce unwanted pregnancy, sponsored by the World Health Organization, Concept Foundation and the Rockefeller Foundation, took place in Bellagio, Italy, between 24 and 28 September 2001. The objective of the conference was to review the scientific information and to evaluate the use of mifepristone for emergency contraception, luteal contraception and menstrual induction. Mifepristone is highly effective for emergency contraception but its advantages and disadvantages in comparison with levonorgestrel need to be further studied. Data indicate that mifepristone alone or in combination with misoprostol has potential for occasional use for women seeking help following repeated unprotected intercourse and/or when the interval between intercourse and treatment is more then 120 h. Administration of mifepristone immediately after ovulation seems to be an effective contraceptive method. However, before it can be used commonly, there is a need for a simple and inexpensive method to identify the right time in the cycle. Once-a-month treatment with mifepristone and misoprostol at the expected time of menstruation is not a practical method due to bleeding irregularities and timing of treatment. Menstrual induction with mifepristone and a suitable prostaglandin analogue is highly effective. A randomized comparison with manual vacuum aspiration is, however, needed before it can be recommended for routine use. (author's)
IPPF OPEN FILE. 1993 Feb; 1.In 1984, in Mexico City, the Reagan administration announced its policy prohibiting USAID from supporting any nongovernmental organization which used its own or US funds for any abortion-related activities. Even though this policy was intended to reduce the incidence of abortion, it had the opposite effect because the cut in funding left some areas of the developing world with no family planning services or information at all. Further, this policy resulted in a loss of $17 million (US) or 25% of the budget of the International Planned Parenthood Federation (IPPF). On January 22, 1993, US President Clinton reversed this policy. IPPF considered President Clinton's action to be a significant event for women's health, human rights, and global development. This reversal will provide family planning services to about 300 million couples who want to practice family planning but could not do so because they did not have access to it. Shortly after President Clinton's announcement, IPPF began writing a proposal to USAID for funds to restore programs that the Mexico City policy eliminated. IPPF hoped the reversal would spark international recognition of the need for safe access to abortion. Other actions President Clinton has taken to promote reproductive health are reversing the Reagan and Bush administrations' rule prohibiting abortion counseling at federally-funded clinics, requesting that the US Food and Drug Administration study the possible marketing of RU-486, removing the ban on abortion in military hospitals, approving regulations allowing fetal tissue research, and appointing an abortion rights advocate as Surgeon General. The Catholic Church opposed all of Clinton's abortion policies. However, many congregations, priests, and Vatican officials are dissatisfied with the Pope's anticontraception position.
TIDSSKRIFT FOR DEN NORSKE LAEGEFORENING. 1991 May 30; 111(14):1729-33.The 4 cornerstones of reproductive health according to the WHO are family maternal care neonatal and infant care, and the control of sexually transmitted diseases. In recent years, the AIDS epidemic has caused concern in the world. The world's population doubled to 4 billion from 1927 to 1974, and it will reach 6 billion by the year 2000. The rate of growth is 1.4% in China and 2% in India vs. .3% in Europe. Contraceptive prevalence is 15-20% in Africa, 30% in South Asia, and 75% in East Asia. Shortage of contraceptives leads to abortion in eastern Europe. In 1985 in the USSR, there were 115.7 abortions/1000 women (mostly married) aged 15-44; and 6.4 million abortions for 5.5 million births in 1989. RU-486 or mifepristone combined with prostaglandin has produced abortion in 90% of first trimester pregnancies. After approval in France in 1987, it was used in 40,000 abortions in the following year. 90% of the estimated annual 500,000 maternal deaths occur in developing countries. In Norway, the rate is fewer than 10/100,000 births vs. 100/100,000 in Jamaica. In the mid-1980s, 26% of rural women in Thailand, 49% in Brazil, 54% in Senegal, and 87% in Morocco went without maternal care. In Norway, infant mortality is 6-8/1000 live births vs. 75-150/1000 in developing countries. A WHO investigation on causes of infertility in 25 countries found a 31% rate of tubal pathology in 5800 couples. In Africa, over 85% f infertility in women was infection related. Venereal diseases and infertility are associated with premarital sexual activity in young people. Various donor agencies and the WHO Special Program of Research, Development, and Research Training in Human Reproduction are providing help and resources including AIDS research.