N/A N=279 Randomized Treatment

Tension Versus Tension- Free Foley Balloon for Cervical Ripening

Induced Vaginal Delivery

Bottom Line

View on ClinicalTrials.gov: NCT05404776 ↗

Enrolled (actual)

279

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Time to Vaginal Delivery — 1608; 1595.5 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Placement of Foley balloon for cervical ripening with tension. (Other); Placement of Foley balloon for cervical ripening without tension. (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: The University of Texas Medical Branch, Galveston
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Vaginal Delivery	1608; 1595.5	—
SECONDARY Number of Participants That Requested Analgesia Following Placement of the Foley Balloon	119; 114	—
SECONDARY Number of Participants That Had a Primary Cesarean Delivery	42; 47	—
SECONDARY Number of Participants With Chorioamnionitis	40; 48	—

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 our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT05404776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.