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Tension-Free catheter may ease labor induction

NCT ID NCT03588585

Knowledge-focused Sponsor: Hawaii Pacific Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether putting tension on a Foley catheter (a tube used to help start labor) makes a difference in how quickly a woman gives birth. Researchers compared tension versus no tension in 86 first-time mothers. The trial was stopped early, so the findings are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Foley transcervical catheter with or without tension
What this could lead to
If successful, this could show that not applying tension to the catheter is just as effective, making the procedure more comfortable for women.
What could go wrong
The trial was terminated early with only 86 participants, so results are limited and may not be reliable. It is a small, single-center study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

86 people

The number who actually took part.

Started

Apr 2018

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Induction of labor affected fetus / newborn

Contacts and locations

Locations

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

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