Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 210
- Locations
- 5
- Primary Endpoint
- Rate of vaginal delivery <24 hours
Study Overview
Brief Summary
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.
Detailed Description
This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: >36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score <6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery <24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •> or = to 36 weeks of gestation
- •Singleton fetus
- •Cephalic presentation
- •Intact membranes and an unripe cervix (Bishop score <6)
Exclusion Criteria
- •Multifetal gestation
- •Rupture of membranes
- •Ripe cervix (Bishop score >6)
- •Active labor
- •Contraindication to vaginal delivery
- •Previous uterine surgery
- •Non-cephalic presentation
- •Fetal macrosomia
Outcomes
Primary Outcomes
Rate of vaginal delivery <24 hours
Secondary Outcomes
- Randomization to delivery interval
- Rate of cesarean delivery for non reassuring fetal status
- Rate of uterine hyperstimulation