A randomized controlled trial to evaluate the use of misoprostol for second trimester pregnancy termination associated with fetal malformation

Background. There is limited information on the effectiveness and safety of misoprostol for second trimester pregnancy termination.; Objectives. To compare misoprostol administered orally or vaginally to intra-amniotic injection of PGF_2α for second trimester pregnancy termination.; Design. Multicentre randomized controlled trial of 3 groups with 240 patients.; Methodology. One interim analysis was performed of data for the first 80 patients enrolled. The decision to stop part or all the trial early was based on finding differences in the time from start of treatment to placental delivery at P < 0.005, more than one maternal death or ≥15% rate of major maternal complications.; Results. Time from start of treatment to placental delivery was longer with oral misoprostol compared with vaginal misoprostol (P < 0.001) or infra-amniotic PGF_2α (P < 0.041). There were no serious maternal complications.; Conclusion. Oral misoprostol is a less effective approach to second trimester pregnancy termination than either vaginal misoprostol or intra-amniotic PGF_2α.