NCT02098421

Foley Labor Induction Trial at Term and in PROM

A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia. Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed. After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).

Detailed description

Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.

Conditions

• Induction of Labor

Interventions

Type	Name	Description
DRUG	Oxytocin	Use of oxytocin while the Foley bulb is in place

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-04-18
• Completion: 2016-04-18
• First posted: 2014-03-28
• Last updated: 2017-06-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study