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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 is a NA study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 150 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04573517
The ClinicalTrials.gov registry entry for NCT04573517 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Foley balloon is the first listed.
NCT04573517 reports 0 study locations.
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.
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