Status:
COMPLETED
Tension Versus Tension- Free Foley Balloon for Cervical Ripening
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Induced Vaginal Delivery
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of...
Detailed Description
This is a pragmatic cluster randomized clinical trial. The target population is nulliparous women who present for induction of labor at term. If there is a decision by the obstetric team to place a tr...
Eligibility Criteria
Inclusion
- Term induction of labor
- Nulliparous
- Vertex
- Singleton
- Plan for Foley balloon placement by the managing obstetrics team
- Cervical exam less than 3 cm dilated and less than or equal to 60% effaced
Exclusion
- Patient unwilling or unable to provide verbal consent
- Fetal demise or major congenital anomaly
- Preterm (\<37 0/7weeks)
- Multiple gestation
- Previous uterine surgery
- Abnormal placentation
- Malpresentation
- Magnesium infusion for preeclampsia with severe features
- Prelabor rupture of membranes
- Fetal growth restriction
- Non-reassuring fetal heart rate tracing prior to inclusion
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT05404776
Start Date
June 3 2022
End Date
June 21 2023
Last Update
August 6 2025
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555