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Early Versus Delayed Artificial Rupture of Membranes (AROM Trial) — AROM  

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:
Early Versus Delayed Artificial Rupture of Membranes Following Foley Catheter Ripening in Labor Induction: A Randomized Controlled Trial (AROM Trial)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn
  • Rupture
Clinical Trial Details
NCT number NCT04496908
Study type Interventional
Source Christiana Care Health Services
Contact
Status Completed
Phase Early Phase 1
Start date September 16, 2020
Completion date October 18, 2021
View Details
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