Status:
COMPLETED
Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
Lead Sponsor:
Christiana Care Health Services
Conditions:
Induction of Labor Affected Fetus / Newborn
Eligibility:
FEMALE
18-55 years
Phase:
EARLY_PHASE1
Brief 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. T...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04496908
Start Date
September 16 2020
End Date
October 18 2021
Last Update
December 3 2021
Active Locations (1)
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1
Christiana Care Health Systems
Newark, Delaware, United States, 19713