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Oxytocin

Pitocin, Syntocinon

Quick Stats
Studies 93
Trials 100
Completed PHASE1 INTERVENTIONAL NCT02098421

Foley Labor Induction Trial at Term and in PROM

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: induction time to delivery
TimeFrame: Time from induction to delivery, average 12-28 hours
Description: The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.

Trial Information

NCT ID

NCT02098421

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Icahn School of Medicine at Mount Sinai

Last Updated

December 15, 2025