BACKGROUND: This study was conducted to compare efficacy and safety of 600 mcg of misoprostol vaginally every 6 h up to four doses vs. 400 mcg of misoprostol vaginally every 4 h up to five doses, followed by systematic curettage of the uterine cavity, for pregnancy termination between 12 and 20 weeks' gestation. STUDY DESIGN: We used a randomized clinical trial conducted at Hospital Gineco-Obstétrico "Eusebio Hernández", Havana, Cuba. Subjects were women requesting voluntary termination of pregnancies between 12 and 20 weeks' gestation. Two hundred ten women were randomly assigned to receive 600 mcg of vaginal misoprostol every 6 h up to four doses (Group I) vs. 400 mcg of vaginal misoprostol every 4 h up to five doses (Group II), followed by curettage 1 h after expulsion. The main outcomes measured were successful abortion rate and mean expulsion time. RESULTS:Successful abortion occurred in 103/105 women (98.1%) in Group I and in 99/105 (94.3%) in Group II [p=.279, relative risk (RR)=3.121 and 95% confidence interval for RR=0.615 to 15.833]. Fetus mean expulsion time was 10.7+/-1.3 (SD) h in Group I and 11.5+/-5.0 (SD) h in Group II (p=.209). CONCLUSIONS: Six hundred micrograms of misoprostol administered vaginally every 6 h was as effective as 400 mcg of misoprostol every 4 h for second-trimester pregnancy termination.
RCT Entities:
BACKGROUND: This study was conducted to compare efficacy and safety of 600 mcg of misoprostol vaginally every 6 h up to four doses vs. 400 mcg of misoprostol vaginally every 4 h up to five doses, followed by systematic curettage of the uterine cavity, for pregnancy termination between 12 and 20 weeks' gestation. STUDY DESIGN: We used a randomized clinical trial conducted at Hospital Gineco-Obstétrico "Eusebio Hernández", Havana, Cuba. Subjects were women requesting voluntary termination of pregnancies between 12 and 20 weeks' gestation. Two hundred ten women were randomly assigned to receive 600 mcg of vaginal misoprostol every 6 h up to four doses (Group I) vs. 400 mcg of vaginal misoprostol every 4 h up to five doses (Group II), followed by curettage 1 h after expulsion. The main outcomes measured were successful abortion rate and mean expulsion time. RESULTS: Successful abortion occurred in 103/105 women (98.1%) in Group I and in 99/105 (94.3%) in Group II [p=.279, relative risk (RR)=3.121 and 95% confidence interval for RR=0.615 to 15.833]. Fetus mean expulsion time was 10.7+/-1.3 (SD) h in Group I and 11.5+/-5.0 (SD) h in Group II (p=.209). CONCLUSIONS: Six hundred micrograms of misoprostol administered vaginally every 6 h was as effective as 400 mcg of misoprostol every 4 h for second-trimester pregnancy termination.