title: Double-blind randomized trial of mifepristone in combination with vaginal gemeprost or misoprostol for induction of abortion up to 63 days gestation.
abstract: 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.
authors.affiliation: Centre for Reproductive Biology, University of Edinburgh, 37 Chalmers Street, Edinburgh EH3 9ET, UK.
authors.forename: J
authors.initials: J
authors.lastname: Bartley
authors.forename: A
authors.initials: A
authors.lastname: Brown
authors.forename: R
authors.initials: R
authors.lastname: Elton
authors.forename: D T
authors.initials: DT
authors.lastname: Baird
mesh_terms: 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
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D016595:Misoprostol; D015735:Mifepristone; C021182:gemeprost; D000527:Alprostadil