Oral misoprostol versus extra amniotic saline infusion for induction of labour in hypertensive disorders of pregnancy >34 weeks gestation: A randomised controlled trial – the MEASI trial

Objective: To compare the efficacy and safety of oral misoprostol with extra-amniotic saline infusion (EASI) for induction of labour in hypertensive disorders of pregnancy (HDP) >34 weeks of gestation.Methods: This was a randomised, open label, parallel arm trial with 1:1 allocation ratio conducted in the Department of Obstetrics and Gynaecology, JIPMER, Pondicherry, India. 176 pregnant women >34 weeks of gestation with HDP admitted for induction of labour with Bishop score < 6 were randomised to receive either oral misoprostol 25μg three hourly upto 4 doses or EASI (22F Foley’s catheter, 60 ml balloon for 12 hours with saline infusion at 30 ml/hour for first 6 hours). Primary outcome of the study was vaginal birth within 24 hours of induction.Results: The proportion of vaginal birth within 24 hours of induction was higher (77.1% vs. 67.8%) and the mean induction to delivery interval was one hour shorter (20.26 ± 4.5 vs. 21.38 ± 4.3 hours) with oral misoprostol when compared to EASI but the difference was not statistically significant. Shivering (17.2%), nausea and vomiting (23%) were more common with oral misoprostol when compared to EASI (5.7% and 13.8% respectively). Uterine tachysystole was observed only with oral misoprostol. Caesarean section (13.7% vs. 14.9%) and neonatal outcomes were similar between the groups.Conclusion: EASI was found to be as effective, although the proportion of women who achieved a vaginal birth within 24 hours was slightly lower with nil occurrence of uterine tachysystole when compared to oral misoprostol for induction of labour in HDP> 34 weeks of gestation.