A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.
Location: Rotunda Hospital, Dublin, Ireland
Chief Investigator: Prof Fergal Malone
The study is expected to enroll 465 mothers in three arms, comparing Dilapan-S® (12 hours insertion) and Dilapan-S® (24 hours insertion) with Propess (24 hours insertion). Expected duration of enrollment period is 18 months – thus study is expected to be completed by mid-2022 and published early 2023.
The primary objective of the study is to demonstrate non-inferiority of efficacy for Dilapan-S® (12 hours or 24 hours insertion) to Propess for outpatient induction of labour at 39 weeks’ gestation in otherwise uncomplicated, normal risk nulliparous women.
The primary outcome measure (efficacy measure) is failure to achieve vaginal delivery (or, equivalently, successful vaginal delivery or SVD) within 36 (12 hour Dilapan-S® group) or 48 hours (24 hour Dilapan-S®/Propess groups) from commencement of induction. This will allow assessment of effective methods of IOL in the outpatient setting.
The study will be completed by mid-2022 and published early 2023!