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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07006896
Status
Recruiting
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Conditions

  • Cesarean Delivery
  • Labor Induction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Foley balloon — DEVICE
    Foley balloon for induction of labor
  • Oxytocin — DRUG
    Pitocin for induction of labor

Study Details

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.

Key Dates

Start date
Jul 10, 2025
Status verified
Jul 2025
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Concurrent Foley balloon and Oxytocin
    Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
  • Active Comparator: 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

Primary Outcome Measure

Time to delivery [ Time Frame: At delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19146
Hannah Foster, MD
[email protected]
267-879-4930

Find similar trials in Philadelphia, PA

By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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