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Erschienen in:
01.06.2011 | Reproductive Medicine
Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial
Erschienen in: Archives of Gynecology and Obstetrics | Ausgabe 6/2011
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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.