Tension Versus Tension- Free Foley Balloon for Cervical Ripening

July 18, 2025 updated by: The University of Texas Medical Branch, Galveston

Tension Versus Tension-Free Foley Balloon for Cervical Ripening in Nulliparous Women Undergoing Induction of Labor: A Cluster Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Without tension (tension free)
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.
A Foley balloon will be placed for cervical ripening without tension.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Vaginal Delivery
Time Frame: Foley bulb placement to vaginal delivery, up to 24 Hours
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
Foley bulb placement to vaginal delivery, up to 24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Requested Analgesia Following Placement of the Foley Balloon
Time Frame: Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)
Request for IV pain medications or epidural following placement of Foley balloon
Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)
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 that had a primary cesarean delivery
Placement of Foley balloon until cesarean delivery, up to 24 Hours
Number of Participants With Chorioamnionitis
Time Frame: Placement of Foley balloon until delivery, up to 24 Hours
Number of participants with chorioamnionitis
Placement of Foley balloon until delivery, up to 24 Hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Postpartum Hemorrhage
Time Frame: Placement of Foley balloon until 24 hours postpartum
Number of participants with postpartum hemorrhage
Placement of Foley balloon until 24 hours postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Meagan V Benson, DO, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2022

Primary Completion (Actual)

June 21, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-0327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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