Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial

Abstract

Aim: To compare the efficacy of different intervals of misoprostol administration (simultaneously vis-à-vis 24 h), after mifepristone, in women undergoing medical termination of pregnancy up to gestation of 49 days.

Methods: Eighty eligible women with single intrauterine pregnancy of ≤ 7 weeks of gestation requesting abortion were randomized to receive either 200 mg of mifepristone orally and 400 μg of misoprostol vaginally simultaneously (Group 1) or at 24-h interval (Group 2).Women who had no bleeding after the drugs were offered a second dose of misoprostol 24 h after the first dose. All patients were followed up on day 14. Primary outcome measure was the complete abortion rate. Secondary outcome measures were the induction-abortion interval, adverse effects, especially bleeding, and treatment acceptability rate. Treatment was considered a failure if surgical intervention was needed for any indication.

Results: Complete abortion was achieved in 38 women [95%; 95% confidence interval (CI) 88%, 100%] in Group 1 and 39 women (97.50%; 95% CI 93%,100%) in Group 2 (p = 0.56). A second dose of misoprostol was needed in two patients in Group 1 and in only one patient in Group 2. The induction-abortion interval was 6.50 ± 1.48 h in Group 1 and 5.95 ± 1.81 h in Group 2 (p = 0.13). The difference in frequency of adverse effects in the two groups was statistically insignificant (p = 0.18). The treatment acceptability rate was 97.50% in Group 1 and 95% in Group 2 (p = 0.56).

Conclusion: Simultaneous administration of mifepristone and 400 μg vaginal misoprostol is an effective alternative to standard regimens for medical abortion up to 49 days of gestation.