Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
Completed · Early Phase 1
Conditions studied: Induction of Labor Affected Fetus / Newborn
In brief
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
Key facts
- Study ID
- NCT04496908
- Run by
- Christiana Care Health Services
- People needed
- 160
- Starts
- 2020-09-16
- Expected to finish
- 2021-10-18
- Last updated by the study team
- 2021-12-03
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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.
Where it is running
- Christiana Care Health Systems — Newark, Delaware, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.