Efficacy of mifepristone followed on the same day by misoprostol for earlytermination 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 un dergoing medical termination of pregnancy whose pregnancies have a gestatio nal age up to 49 days. Design Prospective, randomised trial. Setting Clinical reseal ch office. Participants Eighty-six women, requesting elective termination of a pregnan cy which has a gestational age of less than or equal to 49 days. Methods After administration of mifepristone 600 mg, participants were rand omised to take misoprostol six to eight hours later (Group 1) or 48 hours l ater (Group 2). Women returned for a follow up evaluation 24 +/- 1 hours af ter taking the misoprostol. Participants in Group 1 who had not aborted rec eived a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. I f 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 administrati on 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 c omplete 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 mis oprostol 400 mug orally on the same day is not as effective at causing abor tion within the first 24 hours compared with the standard time interval of 48 hours between medications.