Elective induction of labor versus expectant management at 39 weeks among low-risk nulliparous pregnant women: A randomized controlled trial in India (ELITE-39 trial).

Abstract

The aim of the present open label randomized controlled trial was to compare the rate of cesarean section (CS) after elective induction with that of expectant management in low-risk nulliparous women at 39 weeks. This randomized controlled trial from a tertiary maternity care center enrolled low risk nulliparous pregnant women at 38-38+4 weeks between April 1, 2019 and December 31, 2021. Participants were randomized into either the elective induction group (e-IOL) or the expectant management (EM) group though computer generated block randomization. The primary outcome was cesarean rate and the secondary outcome include adverse maternal and perinatal outcome between e-IOL and EM groups. We performed intention to treat analysis. A total of 360 women were enrolled into the present study. Analysis was performed for 179 women in the e-IOL group and 180 women in the EM group. The baseline demographic characteristics including Bishop score were comparable between the groups. The CS rate in both groups was 17.3% (31/179) and 25% (45/180), which is comparable (P = 0.08). There was one intrapartum stillbirth in the e-IOL group, and two babies succumbed in the neonatal period in the EM group. The maternal and perinatal outcomes between the groups were not found to be significantly different. Elective induction of low-risk nulliparous women at 39 weeks was not associated with increased cesarean section rate. The maternal and perinatal outcomes were comparable. Large, multicentric real time randomized controlled trials are needed to understand the benefit of elective induction in low-risk nulliparous women. This should include centers with large volume of deliveries especially from emerging countries also.