Clinical trial NCT07006896: Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin
Official title: Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor Induction
Cesarean Delivery
Keywords: Labor
Induction
Cesarean
TOLAC
Foley
Oxytocin
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to delivery
timeFrame: At delivery
Secondary outcomes:
measure: Estimated postpartum blood loss
timeFrame: At delivery
measure: Postpartum hemorrhage
timeFrame: Within 6 weeks of delivery
measure: Chorioamnionitis
timeFrame: At delivery
measure: Mode of delivery
timeFrame: At delivery
measure: Uterine rupture
timeFrame: At delivery
measure: Maternal morbidity
timeFrame: Within 6 weeks of delivery
measure: Neonatal morbidity
timeFrame: Within 6 weeks of delivery
measure: Maternal length of stay
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: Neonatal length of stay
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: NICU stay greater than 48 hours
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)
timeFrame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Lisa Levine, MD MSCE
role: PRINCIPAL_INVESTIGATOR
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