Overview

Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

Status:
Completed
Trial end date:
2021-10-18
Target enrollment:
Participant gender:
Summary
This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
Phase:
Early Phase 1
Details
Lead Sponsor:
Christiana Care Health Services
Treatments:
Misoprostol