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: 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.
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Authors | |
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)
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Chemical References |
- Abortifacient Agents, Nonsteroidal
- Mifepristone
- gemeprost
- Alprostadil
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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
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