Comparing two regimens of intravaginal misoprostol with intravaginal gemeprost for second-trimester pregnancy termination: a randomised controlled trial.

Aim To compare the efficacy and safety of intravaginal misoprostol 200 mu g, 400 mu g and gemeprost regimens for second-trimester termination of pregnancy (TOP). Methods A three-armed randomi sed controlled trial (Clinical Trial Certificate 1100015) where 116 women undergoing second-trimester TOP were given intravaginal misoprostol 200 mu g (n=37), misoprostol 400 mu g (n=40) or gemeprost 1 mg (n=39) at 4-hour intervals until abortion occurred with a maximum of five doses. Results The misoprostol 400 mu g group had the highest incidence of successful abortions (92.5%) compared to the misoprostol 200 mu g (70.3%; p=0.017) and gemeprost 1 mg (74.4%; p=0.037) within 48 hours. There was no significant difference in abortion rate between misoprostol 200 mu g and gemeprost. The misoprostol 400 mu g group had the highest incidence of fever (70.0%) compared to misoprostol 200 mu g (24.3%; p< 0.001) and gemeprost 1 mg (46.2%; p=0.041). The gemeprost group had the highest incidence of diarrhoea (38.5%) compared to misoprostol 400 mu g (10.0%; p=0.004) and misoprostol 200 mu g (8.1%; p=0.003) groups. Conclusions Intravaginal misoprostol 400 mu g at 4-hour intervals was the most effective regimen but was associated with a high incidence of fever. Misoprostol 200 mu g demonstrated similar effectiveness as gemeprost and had lower incidence of diarrhoea. Gemeprost should not be first line for medical therapy given the cost, storage requirements and lower efficacy.