Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin

Not Applicable

Recruiting

• Conditions: Labor Induction; Cesarean Delivery
• Interventions: Device: Foley balloon; Drug: Oxytocin

• Registration Number: NCT07006896
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Study First Posted: 2025-06-05
• Status Verified: 2025-07
• Study Start: 2025-07-10
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent Foley balloon and Oxytocin	Foley balloon	Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Concurrent Foley balloon and Oxytocin	Oxytocin	Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Foley balloon alone	Foley balloon	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

Primary Outcome Measures

Name	Time	Method
Time to delivery	At delivery	The primary endpoint will be time from start of induction until delivery (hours)

Secondary Outcome Measures

Name	Time	Method
Estimated postpartum blood loss	At delivery	Estimated postpartum blood loss in mL
Postpartum hemorrhage	Within 6 weeks of delivery	Estimated blood loss≥ 1L
Number of Participants with Chorioamnionitis	At delivery	Documented chorioamnionitis
Mode of delivery	At delivery	Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)
Number of Participants with Uterine Rupture	At delivery	Uterine rupture noted at the time of cesarean delivery
Maternal morbidity	Within 6 weeks of delivery	Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolism and hospital readmission with 6 weeks
Neonatal morbidity	Within 6 weeks of delivery	Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis
Maternal length of stay	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Measured by hours from admission to postpartum discharge
Neonatal length of stay	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Length of stay from birth to discharge, measured in hours
NICU stay greater than 48 hours	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery	Admission to the NICU for more than 48 hours
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	Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States