Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

Christiana Care Health Services

Status and phase: Completed; Early Phase 1

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Procedure: amniotomy; Device: Foley Catheter; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04496908

DDD# 604698

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• full term (≥37 weeks) gestations determined by routine obstetrical guidelines
• singleton gestation in cephalic presentation
• Both nulliparous and multiparous women
• Intact membranes
• Bishop score of ≤6 and cervical dilation ≤2cm

Exclusion criteria

• Any contraindication to a vaginal delivery or to misoprostol
• fetal demise
• Multifetal gestation
• major fetal anomaly
• prior uterine surgery, previous cesarean section
• women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage
• Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Early Amniotomy

Active Comparator group

Description:

Women in the Early AROM group will under amniotomy one hour from Foley Catheter expulsion. Labor augmentation will continue per study protocol. Refer to Appendix A for protocol regimen.

Treatment:

Procedure: amniotomy

Device: Foley Catheter

Drug: Misoprostol

Delayed Amniotomy

Active Comparator group

Description:

Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.

Treatment:

Procedure: amniotomy

Device: Foley Catheter

Drug: Misoprostol