N/A
Completed N=279
Tension Versus Tension- Free Foley Balloon for Cervical Ripening
Induced Vaginal Delivery
Source: ClinicalTrials.gov NCT05404776 ↗
Enrolled (actual)
279
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Time to Vaginal Delivery — 1608; 1595.5 minutes
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.
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 | — |
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
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. Informational only — not medical advice.