Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial

Objective To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400 mug orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days. Design Prospective, randomised trial. Setting Clinical reseal ch office. Participants Eighty-six women, requesting elective termination of a pregnancy which has a gestational age of less than or equal to 49 days. Methods After administration of mifepristone 600 mg, participants were randomised to take misoprostol six to eight hours later (Group 1) or 48 hours later (Group 2). Women returned for a follow up evaluation 24 +/- 1 hours after taking the misoprostol. Participants in Group 1 who had not aborted received a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. If termination of pregnancy had still not occurred and the pregnancy was non-viable, the woman returned again in three weeks. Main outcome measures Rate of complete abortion 24 hours after administration of misoprostol. Results At 24 hours after receiving misoprostol, 21/42 (50%, 95% CI 35%, 65%) women in Group 1 and 40/44 (91%, 95% CT 82%, 99%) women in Group 2 had complete abortions. By follow up two weeks later after the administration of mifepristone, 40/42 (95%, 95% CI 89%, 100%) women in Group 1 and 43/44 (98%, 95% CI 93%, 99%) women in Group 2 were known to have complete abortions. Nausea, vomiting or diarrhoea in women using the standard regimen (Group 2) occurred in 68%, 36%, and 20%, respectively. Conclusions After treatment with mifepristone 600 mg, administration of misoprostol 400 mug orally on the same day is not as effective at causing abortion within the first 24 hours compared with the standard time interval of 48 hours between medications.