Foley catheter alone versus Foley plus oxytocin to start labor after one prior cesarean
Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin
This trial will test whether starting oxytocin at the same time as a Foley catheter helps people with one prior cesarean deliver faster during a planned induction at term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07006896 on ClinicalTrials.gov |
What this trial studies
This randomized trial enrolls people with a single pregnancy at ≥37 weeks and one prior cesarean who are scheduled for induction with a Foley catheter. Participants are randomly assigned to cervical ripening with a Foley balloon alone or to a Foley plus concurrent oxytocin infusion started at the time of catheter placement. The primary outcome is time to delivery, and the study will also monitor maternal and neonatal safety outcomes such as uterine rupture, cesarean delivery, and infection. The trial is conducted at the Hospital of the University of Pennsylvania using standard clinical protocols for Foley placement and oxytocin administration.
Who should consider this trial
Good fit: Ideal candidates are people aged 18 or older at ≥37 weeks with a single, cephalic pregnancy, intact membranes, one prior cesarean, cervical dilation <3 cm and Bishop score <8, who plan induction with a Foley catheter and can consent in English or Spanish.
Not a fit: People with more than one prior cesarean, known chorioamnionitis, major fetal anomalies, ruptured membranes, or non-cephalic presentation are unlikely to qualify or benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could shorten the time to delivery for people attempting labor after cesarean without adding significant risks.
How similar studies have performed: Smaller randomized and observational studies have suggested concurrent Foley plus oxytocin can shorten induction time without increasing maternal or neonatal complications, but results are limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Levine, MD MSCE — University of Pennsylvania
- Study coordinator: Hannah Foster, MD, MAUB
- Email: hannah.foster@pennmedicine.upenn.edu
- Phone: 16105857323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.