Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Time to delivery
Study Overview
Brief Summary
A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction. With this trial, the investigators aim to test our central hypothesis that concurrent Foley and Oxytocin will decrease time to delivery without increasing risks, compared to Foley alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible for induction of labor
- •Live singleton gestation ≥37 weeks
- •History of 1 cesarean delivery
- •≥18 years of age
- •Cephalic presentation
- •Intact membranes
- •English or Spanish speaking (Able to read/understand consent and instructions)
- •Cervical dilation <3cm and Bishop score <8
Exclusion Criteria
- •>1 prior Cesarean delivery
- •Known chorioamnionitis
- •Major fetal anomaly
Arms & Interventions
Foley balloon alone
Cervical ripening will begin with a Foley balloon alone. Oxytocin will not be started until the balloon is removed or expelled, though can be considered if the balloon remains in place for >8 hours
Intervention: Foley balloon (Device)
Concurrent Foley balloon and Oxytocin
Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Intervention: Foley balloon (Device)
Concurrent Foley balloon and Oxytocin
Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Intervention: Oxytocin (Drug)
Outcomes
Primary Outcomes
Time to delivery
Time Frame: At delivery
The primary endpoint will be time from start of induction until delivery (hours)
Secondary Outcomes
- Number of Participants with Uterine Rupture(At delivery)
- Estimated postpartum blood loss(At delivery)
- Postpartum hemorrhage(Within 6 weeks of delivery)
- Number of Participants with Chorioamnionitis(At delivery)
- Mode of delivery(At delivery)
- Maternal morbidity(Within 6 weeks of delivery)
- Neonatal morbidity(Within 6 weeks of delivery)
- Maternal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Neonatal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- NICU stay greater than 48 hours(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
- Mode of delivery(At delivery)
- Estimated postpartum blood loss(At delivery)
- Postpartum hemorrhage(Within 6 weeks of delivery)
- Maternal morbidity(Within 6 weeks of delivery)
- Neonatal morbidity(Within 6 weeks of delivery)
- Maternal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Neonatal length of stay(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- NICU stay greater than 48 hours(From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery)
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)(From time of delivery to discharge from hospital, up to 6 weeks from delivery)
Investigators
Lisa Levine
Associate Professor
University of Pennsylvania