Status:
WITHDRAWN
Foley Catheter Induction
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Labor Induction
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The foley catheter (single lumen balloon) is one of the most cost effective, readily available methods for cervical ripening to begin an induction of labor. It is most commonly used in conjunction wit...
Detailed Description
The study team's goal is to conduct a randomized controlled trial in nulliparous and multiparous patients to determine the optimal length of time to retain foley catheters (single balloon) for inducti...
Eligibility Criteria
Inclusion
- Age 18 through 50 years old
- Bishop score of 6 or less
- Singleton pregnancies at 37 weeks or more
- Absence of labor or rupture of membranes.
Exclusion
- COVID positive patients
- Previous history of cesarean delivery
- Ruptured membranes (the institutional policy states women cannot have foley catheters placed if membranes are ruptured)
- Documented labor on admission (will include only patients being induced)
- Fetal distress on admission (e.g. indication for induction of labor being category 2 tracing as these patients may have increased risk of cesarean delivery)
- Certain fetal anomalies (e.g. brain anomalies, abdominal wall or neural tube defects, fetal cardiac arrhythmias)
- Contraindication to vaginal delivery
Key Trial Info
Start Date :
November 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05257187
Start Date
November 7 2021
End Date
March 1 2022
Last Update
November 18 2023
Active Locations (1)
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1
Mount Sinai West
New York, New York, United States, 10019