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NCT04573517 · ClinicalTrials.gov registry record · NA
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor
A NA study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT04573517: Completed NA study, sponsored by The University of Texas Medical Branch, Galveston.
NCT04573517 is a NA study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04573517, a NA study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
Primary Outcome
Total time from initiation of labor induction to reaching 6 cm cervical dilation
Interventions
- DEVICE Foley balloon
- PROCEDURE Amniotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2023-06-22 |
| Phase | NA |
What the finished NCT04573517 record still lists
NCT04573517 is an interventional study that assigns participants to a tested intervention. The registered 150 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 (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Foley balloon is the first listed.
NCT04573517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04573517 about?
NCT04573517 is a clinical study titled "Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor". Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, howev...
What is the current status of trial NCT04573517?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2020-10-15. Estimated completion is 2023-06-22.
What interventions are being tested in trial NCT04573517?
The interventions under investigation include: Foley balloon (DEVICE), Amniotomy (PROCEDURE).
Who is sponsoring clinical trial NCT04573517?
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 NCT04573517's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 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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