TerminatedNot Applicable

Tension Versus no Tension With Foley Bulb Induction

Stopped: Study terminated due to low enrollment.

United States86 participantsStarted 2018-04-16

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Delivery

Timeframe: Will measure length of time from beginning of induction with the foley balloon until delivery

Trial details

NCT IDNCT03588585

SponsorHawaii Pacific Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-09

View on ClinicalTrials.gov More Induction of Labor Affected Fetus / Newborn trials