Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation.
BACKGROUND
Gemeprost and misoprostol are two of the most widely used prostaglandins in combination with mifepristone for medical abortion in early pregnancy. However, the efficacy and side-effects of those two drugs given vaginally have not been assessed in a randomized trial.


METHODS
Randomized double-blind controlled trial involving 999 women undergoing an abortion at gestational age < or =63 days who received either 0.5 mg gemeprost (group I, n = 499) or 800 microg misoprostol (group II, n = 500) vaginally approximately 48 h after taking 200 mg mifepristone by mouth. The rate of complete abortion and the side-effects were compared between the groups.


RESULTS
A total of 89 cases was excluded from full analysis of outcome because either they aborted after mifepristone alone (n = 2), had an ectopic pregnancy (n = 1), or because the outcome was uncertain as they failed to attend their follow-up appointment (n = 86). The rate of complete abortion was very high (>95%) in both groups but significantly higher after treatment with misoprostol than with gemeprost [436/453 (98.7%) versus 451/457 (96.2%), P = 0.019, difference 2.5%, confidence interval 0.4-4.7%] and there were fewer ongoing pregnancies (n = 1 versus n = 8, P < 0.018). Surgical intervention rose significantly with gestation in women who received gemeprost (P < 0.03) but not with misoprostol. The incidence of side-effects such as diarrhoea (13.7 versus 16.4%) and vomiting (27.8 versus 29.7%) was similar in women who received misoprostol or gemeprost respectively, as was the duration and amount of bleeding.


CONCLUSIONS
(i) Both regimens using a reduced dose of mifepristone are highly effective methods of inducing abortion in early pregnancy; (ii) vaginal misoprostol is the preferred prostaglandin because it is it is associated with fewer failures than low-dose gemeprost, particularly at gestation > or =49 days.
Bartley
J
J
Centre for Reproductive Biology, University of Edinburgh, 37 Chalmers Street, Edinburgh EH3 9ET, UK.
Brown
A
A
Elton
R
R
Baird
D T
DT
D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D000021:Abortifacient Agents, Steroidal / Q000009:adverse effects / Q000494:pharmacology*; D000028:Abortion, Induced; D000282:Administration, Intravaginal; D000328:Adult; D000527:Alprostadil / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D005865:Gestational Age; D006801:Humans; D015735:Mifepristone / Q000009:adverse effects / Q000494:pharmacology*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D011247:Pregnancy; D016896:Treatment Outcome
D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone; C021182:gemeprost; D000527:Alprostadil