Intravaginal misoprostol alone versus intravaginal misoprostol and extraamniotic Foley catheter for second trimester pregnancy termination: an observational study.

Background: No systematic empirical research exists addressing the question of optimal pregnancy termination method in second trimester pregnancies. Objectives: The purpose of this study was to determine the efficacy and safety of intravaginal misoprostol and extraamniotic Foley catheter combination for second trimester pregnancy termination. Methods: A single center, observational study was conducted in a total of 91 pregnancies. Women who met the termination of pregnancy criteria due to feto-maternal indications between 13 to 26 gestational weeks were included into the study. Study participants received intravaginal misoprostol in combination with Foley catheter (n=46) or intravaginal misoprostol alone (n=45). Results: The efficacy of intravaginal misoprostol and Foley catheter insertion combination was comparable to that of intravaginal misoprostol alone in terms of time to abortion/birth [median (95% Confidential Interval [95% CI]): 14.33 (11.33-17.25) hours and 12.08 (9.50-15.33) hours, respectively. Hazard Ratio: 0.73, 95% CI: 0.47 to 1.12, p= 0.14 (log-rank)]. The only serious maternal event was uterine rupture observed in one woman in Foley combination group. Conclusion: The combination of intravaginal misoprostol and extraamniotic Foley catheter for second trimester pregnancy termination does not provide additional efficacy.