NCT04496908

Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Christiana Care Health Services · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
PROCEDURE	amniotomy	Artificially rupturing membranes
DEVICE	Foley Catheter	Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.
DRUG	Misoprostol	Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.

Timeline

• Start date: 2020-09-16
• Primary completion: 2021-05-22
• Completion: 2021-10-18
• First posted: 2020-08-04
• Last updated: 2021-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study