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

University of Pennsylvania

Status: Enrolling

Conditions: Labor Induction; Cesarean Delivery

Treatments: Device: Foley balloon; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT07006896

858270

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Concurrent Foley balloon and Oxytocin

Experimental group

Description:

Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement

Treatment:

Drug: Oxytocin

Device: Foley balloon

Foley balloon alone

Active Comparator group

Description:

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

Treatment:

Device: Foley balloon