Extra-amniotic saline instillation versus combination of oral mifepristone and vaginal misoprostol for second trimester termination of pregnancy in women with previous one caesarean section: A randomized controlled trial

Abstract

Background: To study and compare the efficacy and safety of extra-amniotic saline instillation (EASI) and combination of oral mifepristone and vaginal misoprostol for second trimester termination of pregnancy in women with previous one caesarean section.Methods: This randomized controlled trial was conducted in Puducherry, South India. Pregnant women aged 18-45 years with history of previous one caesarean section at 16-27+6 weeks of gestation admitted for pregnancy termination were randomized to receive EASI or combination of oral mifepristone and vaginal misoprostol. Efficacy and safety were compared between the groups in an intention-to-treat analysis.Results: There were 50 patients randomized to the EASI (n=25) and oral mifepristone + vaginal misoprostol (n=25) groups. The median induction to abortion interval was 48 vs 60 hours (p value=0.029), need for another method of termination was 16% vs 44% and side effects were 36% vs 8% with combination of oral mifepristone and vaginal misoprostol in comparison to EASI.Conclusion: Combination of oral mifepristone and vaginal misoprostol appears to be more effective than EASI in reducing the induction-abortion interval, need for another method of termination and duration of hospital stay. The maternal safety profile appears to be comparable but requires further studies.