Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07006896

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Labor Induction Cesarean Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLEY BALLOON

Device

Foley balloon for induction of labor

Other names: Foley catheter, Cervical ripening balloon

Oxytocin

Drug

Pitocin for induction of labor

Other names: Pitocin

Primary outcomes

  1. Time to delivery

    Time frame: At delivery

    The primary endpoint will be time from start of induction until delivery (hours)

Secondary outcomes

  1. Estimated postpartum blood loss

    Time frame: At delivery

    Estimated postpartum blood loss in mL

  2. Postpartum hemorrhage

    Time frame: Within 6 weeks of delivery

    Estimated blood loss≥ 1L

  3. Number of Participants with Chorioamnionitis

    Time frame: At delivery

    Documented chorioamnionitis

  4. Mode of delivery

    Time frame: At delivery

    Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)

  5. Number of Participants with Uterine Rupture

    Time frame: At delivery

    Uterine rupture noted at the time of cesarean delivery

  6. Maternal morbidity

    Time frame: 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

  7. Neonatal morbidity

    Time frame: 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

  8. Maternal length of stay

    Time frame: 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

  9. Neonatal length of stay

    Time frame: 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

  10. NICU stay greater than 48 hours

    Time frame: 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

  11. Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin

Acronym: LIFT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.