Termination of pregnancy with reduced doses of mifepristone. World Health Organisation Task Force on Post-ovulatory Methods of Fertility Regulation.

Abstract

OBJECTIVES:

To compare the abortifacient efficacy and side effects of three doses of the antiprogestin mifepristone plus prostaglandin for termination of early pregnancy.

DESIGN:

Randomised, double blind multicentre trial.

SETTING:

11 departments of obstetrics and gynaecology and of family planning, mostly in university hospitals, in seven countries.

SUBJECTS:

1182 women with an early pregnancy (menstrual delay of 7-28 days) requesting abortion.

INTERVENTIONS:

Single doses of 200 mg, 400 mg, or 600 mg mifepristone followed, 48 hours later, by vaginal pessary of 1 mg of the prostaglandin E1 analogue gemeprost.

MAIN OUTCOME MEASURES:

Outcome of treatment; duration and subjective amount of menstrual bleeding; side effects and complications; and concentrations of haemoglobin.

RESULTS:

Outcome was similar with the three doses of mifepristone. Of the 1151 women with known outcome, 95.5% had a complete abortion (364 (93.8%) of those given 200 mg mifepristone, 368 (94.1%) of those given 400 mg, and 367 (94.3%) of those given 600 mg), 3.7% had an incomplete abortion (14 (3.6%), 15 (3.8%), and 14 (3.6%)), 0.3% had a missed abortion (three (0.8%), one (0.3%), and none), and 0.4% had a continuing live pregnancy (two (0.5%), two (0.5%), and one (0.3%)). Of the 43 women who had incomplete abortion, 23 underwent emergency uterine curettage (usually for haemostatic purposes) and three of these women were given a blood transfusion. The numbers of reported complaints, bleeding patterns, and changes in blood pressure and haemoglobin concentrations were similar with the three treatments.

CONCLUSIONS:

For termination of early pregnancy a single dose of 200 mg mifepristone is as effective as the currently recommended dose of 600 mg when used in combination with a vaginal pessary of 1 mg gemeprost.

• Journal: BMJ (Clinical research ed.) (BMJ) Vol. 307 Issue 6903 Pg. 532-7 (Aug 28 1993) ISSN: 0959-8138 [Print] England
• PMID: 8400972 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Abortifacient Agents, Nonsteroidal
• Mifepristone
• gemeprost
• Alprostadil

Topics

• Abortifacient Agents, Nonsteroidal (administration & dosage, adverse effects)
• Abortion, Induced
• Adult
• Alprostadil (administration & dosage, adverse effects, analogs & derivatives)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Mifepristone (administration & dosage, adverse effects)
• Pessaries
• Pregnancy
• Treatment Outcome