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NCT05404776 · ClinicalTrials.gov registry record · NA
Tension Versus Tension- Free Foley Balloon for Cervical Ripening
A NA study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- NA
- Development phase
- 279
- Enrollment target
NCT05404776: Completed NA study, sponsored by The University of Texas Medical Branch, Galveston.
NCT05404776 is a NA study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 279 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05404776, a NA study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- NA
- Development phase
- 279 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
Interventions
- OTHER Placement of Foley balloon for cervical ripening with tension.
- OTHER Placement of Foley balloon for cervical ripening without tension.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2022-06-03 |
| Est. Completion | 2023-06-21 |
| Phase | NA |
What the finished NCT05404776 record still lists
NCT05404776 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placement of Foley balloon for cervical ripening with tension. is the first listed.
NCT05404776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05404776 about?
NCT05404776 is a clinical study titled "Tension Versus Tension- Free Foley Balloon for Cervical Ripening". 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 hav...
What is the current status of trial NCT05404776?
This trial is currently completed. It is a NA study. The enrollment target is 279 participants. The study started on 2022-06-03. Estimated completion is 2023-06-21.
What interventions are being tested in trial NCT05404776?
The interventions under investigation include: Placement of Foley balloon for cervical ripening with tension. (OTHER), Placement of Foley balloon for cervical ripening without tension. (OTHER).
Who is sponsoring clinical trial NCT05404776?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05404776's enrollment target sits among peer trials
279 381st of 2000 higher than 1,619 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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