Objectives-To compare the abortifacient efficacy and side effects of t
hree doses of the antiprogestin mifepristone plus prostaglandin for te
rmination of early pregnancy. Design-Randomised, double blind multicen
tre 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 d
ays) 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 measu
res-Outcome of treatment; duration and subjective amount of menstrual
bleeding; side effects and complications; and concentrations of haemog
lobin. Results-Outcome was similar with the three doses of mifepriston
e. 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 inc
omplete abortion (14 (3.6%), 15 (3.8%), and 14 (3.6%)), 0.3% had a mis
sed abortion (three (0.8%), one (0.3%), and none), and 0.4% had a cont
inuing 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, bl
eeding patterns, and changes in blood pressure and haemoglobin concent
rations were similar with the three treatments. Conclusions-For termin
ation of early pregnancy a single dose of 200 mg mifepristone is as ef
fective as the currently recommended dose of 600 mg when used in combi
nation with a vaginal pessary of 1 mg gemeprost.