Foley Labor Induction Trial at Term and in PROM
Completed · Phase 1
Conditions studied: Induction of Labor
In brief
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).
Key facts
- Study ID
- NCT02098421
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 312
- Starts
- 2014-11-01
- Expected to finish
- 2016-04-18
- Last updated by the study team
- 2017-06-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
You may not qualify if…
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
Where it is running
- Elmhurst Hospital Center — Elmhurst, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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