An interventional study of Placement of Foley balloon for cervical ripening with tension. and Placement of Foley balloon for cervical ripening without tension. in Induced Vaginal Delivery, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment
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.
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 transcervical Foley dilator for cervical ripening in a prospective subject meeting inclusion criteria for the study, the obstetric provider will follow the weekly randomization sequence for study group (No Tension) or the control group (Tension) based on the assigned cluster for the entire unit for that week. Both study groups will receive standardized labor management as Foley balloon placed with tension and without tension are both considered standard of care at our institution.
The Tension standard of care (control group) will undergo induction of labor by placement of a transcervical Foley balloon, which is standard of care at our institution. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
The No Tension standard of care (study group) will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Subjects in the control and study group will then undergo standard intrapartum care. The total participation time in the study will be considered terminated following delivery.
The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Other: Placement of Foley balloon for cervical ripening without tension.
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Other: Placement of Foley balloon for cervical ripening with tension.
A Foley balloon will be placed for cervical ripening with tension.
A Foley balloon will be placed for cervical ripening without tension.
Time to Vaginal Delivery
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
Time frame: Foley bulb placement to vaginal delivery, up to 24 Hours
Number of Participants That Requested Analgesia Following Placement of the Foley Balloon
Request for IV pain medications or epidural following placement of Foley balloon
Time frame: Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)
Number of Participants That Had a Primary Cesarean Delivery
Number of participants that had a primary cesarean delivery
Time frame: Placement of Foley balloon until cesarean delivery, up to 24 Hours
Number of Participants With Chorioamnionitis
Number of participants with chorioamnionitis
Time frame: Placement of Foley balloon until delivery, up to 24 Hours
Number of Participants With Postpartum Hemorrhage
Number of participants with postpartum hemorrhage
Time frame: Placement of Foley balloon until 24 hours postpartum
| Milestone | Without Tension (Tension Free) | Tension |
|---|---|---|
| Started | 141 | 138 |
| Completed | 141 | 138 |
| Not completed | 0 | 0 |
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
| minutes | Without Tension (Tension Free) | Tension |
|---|---|---|
| Time to Vaginal Delivery | 1608 (430 to 3438) | 1595.5 (507 to 3323) |
Request for IV pain medications or epidural following placement of Foley balloon
| Participants | Without Tension (Tension Free) | Tension |
|---|---|---|
| Number of Participants That Requested Analgesia Following Placement of the Foley Balloon | 119 | 114 |
Number of participants that had a primary cesarean delivery
| Participants | Without Tension (Tension Free) | Tension |
|---|---|---|
| Number of Participants That Had a Primary Cesarean Delivery | 42 | 47 |
Number of participants with chorioamnionitis
| Participants | Without Tension (Tension Free) | Tension |
|---|---|---|
| Number of Participants With Chorioamnionitis | 40 | 48 |
Number of participants with postpartum hemorrhage
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Without Tension (Tension Free) | 0/141 (0%) | 0/141 (0%) | 0/141 (0%) |
| Tension | 0/138 (0%) | 0/138 (0%) | 0/138 (0%) |
| Age, Continuous(years) | Without Tension (Tension Free) | Tension | Total |
|---|---|---|---|
| Median | 23 (18 to 39) | 22 (18 to 42) | 22 (18 to 42) |
| Sex: Female, Male(Participants) | Without Tension (Tension Free) | Tension | Total |
|---|---|---|---|
| Female | 141 | 138 | 279 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Without Tension (Tension Free) | Tension | Total |
|---|---|---|---|
| Hispanic or Latino | 94 | 88 | 182 |
| Not Hispanic or Latino | 47 | 50 | 97 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Without Tension (Tension Free) | Tension | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 4 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 20 | 14 | 34 |
| White | 115 | 122 | 237 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Without Tension (Tension Free) | Tension | Total |
|---|---|---|---|
| United States | 141 | 138 | 279 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Study records will be kept confidential as required by law. No IPD will be shared outside of UTMB. Identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). The data collected will be kept on a password-secured UTMB computer. An encrypted USB flash drive will be used to transfer data. During analysis of the data, all identifiers will be deleted.
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The University of Texas Medical Branch, Galveston