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Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)

Christiana Care Health Services logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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