An interventional study of Foley balloon and Oxytocin in Labor Induction and Cesarean Delivery, sponsored by University of Pennsylvania. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Device: Foley balloon · Drug: Oxytocin
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
Device: Foley balloon
Foley balloon for induction of labor
Also known as: Foley catheter, Cervical ripening balloon
Pitocin for induction of labor
Also known as: Pitocin
Time to delivery
The primary endpoint will be time from start of induction until delivery (hours)
Time frame: At delivery
Estimated postpartum blood loss
Estimated postpartum blood loss in mL
Time frame: At delivery
Postpartum hemorrhage
Estimated blood loss≥ 1L
Time frame: Within 6 weeks of delivery
Number of Participants with Chorioamnionitis
Documented chorioamnionitis
Time frame: At delivery
Mode of delivery
Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)
Time frame: At delivery
Number of Participants with Uterine Rupture
Uterine rupture noted at the time of cesarean delivery
Time frame: At delivery
Maternal morbidity
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
Time frame: Within 6 weeks of delivery
Neonatal morbidity
Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis
Time frame: Within 6 weeks of delivery
Maternal length of stay
Measured by hours from admission to postpartum discharge
Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Neonatal length of stay
Length of stay from birth to discharge, measured in hours
Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
NICU stay greater than 48 hours
Admission to the NICU for more than 48 hours
Time frame: 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)
Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction
Time frame: From time of delivery to discharge from hospital, up to 6 weeks from delivery
Plan to share: No
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania