Slow‐release vaginal insert of misoprostol versus orally administrated solution of misoprostol for the induction of labour in primiparous term pregnant women: a randomised controlled trial

Objective To compare the World Health Organization (WHO) recommended orally administrated dosage of misoprostol (25 μg) with a vaginal slow‐release (7 μg/hour) insert of misoprostol regarding time from induction to delivery and safety of the method. Design Open label, Randomised controlled trial (RCT). Setting Delivery ward at a secondary referral hospital in Stockholm, Sweden, from 1 October 2016 to 21 February 2018. Population One hundred and ninety‐six primiparous women with singletons in cephalic presentation at ≥37 weeks of gestation and with a Bishop score of ≤4. Methods Women were randomised to an oral solution of misoprostol (Cytotec® n = 99) or vaginal slow‐release misoprostol (Misodel® [MVI] n = 97). Main outcome measures Primary outcome: time from induction to vaginal delivery. Secondary outcomes: mode of delivery; proportion of vaginal deliveries within 24 hours (VD24); neonates with an Apgar score of