Randomized controlled trial of misoprostol for second-trimester pregnancy termination associated with fetal malformation

Objective Our purpose was to compare the effectiveness, womenʹs views of the termination procedure, and success of umbilical cord culture for vaginal and oral misoprostol versus intra-amniotic prostaglandin PGF2α for second-trimester pregnancy termination (STPT). Study design We randomized 217 women, 15 to 24 weeksʹ gestation, into 3 groups. Oral (OM) and vaginal (VM) misoprostol groups received 400 μg of misoprostol every 4 hours for 24 hours. The intra-amniotic PGF2α (IAPG) group received 40 mg of PGF2α followed by oxytocin infusion. Women completed self-administered questionnaires 3 weeks after the termination procedure. Umbilical cord samples were collected at delivery for karyotype analysis. The primary outcome was the time from start of the procedure to placental delivery. Secondary outcomes were maternal complications, womenʹs acceptance of the termination procedure, and success rates of umbilical cord culture. Results The time was longer for the OM group (30.5±14.4 hours) compared with the VM group (18.3±8.2 hours) and the IAPG group (21.1±10.2 hours), P<.001 for both comparisons. Women in the VM group reported being more willing to repeat the termination method in the future and reported fewer side effects than those in the other groups, P<.001. Failure rates for umbilical cord cultures were 9.6%, 17.0%, and 45.6% for the VM, OM, and IAPG groups, respectively. Conclusion Oral misoprostol is less effective than intra-amniotic PGF2α or vaginal misoprostol for STPT. Women report vaginal misoprostol more acceptable than other methods. Umbilical cord culture failure rate is highest in the IAPG group.