Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Registration Number
- NCT04496908
- Lead Sponsor
- Christiana Care Health Services
- 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.
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- ≥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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Amniotomy amniotomy 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. Early Amniotomy Foley Catheter 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. Delayed Amniotomy amniotomy Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given. Delayed Amniotomy Foley Catheter Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given. Early Amniotomy Misoprostol 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. Delayed Amniotomy Misoprostol Women in the Delayed AROM group will undergo amniotomy at the discretion of the obstetrician or labor provider. No specific instructions will be given.
- Primary Outcome Measures
Name Time Method time to delivery Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours. time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.
- Secondary Outcome Measures
Name Time Method Blood transfusion through study completion, an average of 1 year binary; yes/no
Time to vaginal delivery At time of delivery time to delivery (hours) defined as time from Foley Catheter expulsion to delivery
Indication for cesarean delivery At time of delivery discrete
Cesarean delivery rate At time of delivery binary; yes/no
3rd/4th degree perineal laceration at time of delivery binary; yes/no
Chorioamnionitis At time of delivery defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
Wound separation-infection through study completion, an average of 1 year binary, yes/no; defined by the need for additional wound closure or the need for antibiotics
Neonatal death through study completion, an average of 1 year binary, yes/no
Maternal length of stay through study completion, an average of 4 days time from admission to discharge
Endometritis From time of delivery to time of hospital discharge; up to 6 weeks binary; yes/no
Trial Locations
- Locations (1)
Christiana Care Health Systems
🇺🇸Newark, Delaware, United States