Tension Versus no Tension With Foley Bulb Induction

February 17, 2026 updated by: Holly Olson, Hawaii Pacific Health

A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.

Study Type

Interventional

Enrollment (Actual)

86

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
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
  • Cephalic presentation
  • Intact fetal membranes
  • Bishop score less than or equal to 6
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • Multiparas
  • Multiple gestation
  • Previous uterine/cervical surgery
  • Ruptured fetal membranes
  • Fetal malpresentation
  • Any contraindication to vaginal delivery at time of admission

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
Active Comparator: Tension
foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.
Procedure: Tension
Tension applied to catheter and taped firmly to leg.
Other Names:
  • misoprostil 25 mcg
Active Comparator: No tension
The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.
Procedure: NO TENSION
Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same
Other Names:
  • misoprostil 25 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Delivery
Time Frame: Will measure length of time from beginning of induction with the foley balloon until delivery
Reduction in time to delivery
Will measure length of time from beginning of induction with the foley balloon until delivery

Collaborators and Investigators

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

Sponsor

Hawaii Pacific Health

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)

April 16, 2018

Primary Completion (Actual)

February 9, 2026

Study Completion (Actual)

February 9, 2026

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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