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NCT04496908 · ClinicalTrials.gov registry record · Early Phase 1
Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
A Early Phase 1 study, sponsored by Christiana Care Health Services.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 160
- Enrollment target
NCT04496908: Completed Early Phase 1 study, sponsored by Christiana Care Health Services.
NCT04496908 is a Early Phase 1 study that has completed, run by Christiana Care Health Services. The registered enrollment target is 160 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04496908, a Early Phase 1 study, has completed, sponsored by Christiana Care Health Services.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 160 participants
- Enrollment target
Study Summary
This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
Primary Outcome
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.
Interventions
- DRUG Misoprostol
- DEVICE Foley Catheter
- PROCEDURE amniotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2021-10-18 |
| Phase | Early Phase 1 |
What the finished NCT04496908 record still lists
NCT04496908 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (202% higher).
The record links to 0 conditions, and to 3 interventions - of which Misoprostol is the first listed.
NCT04496908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04496908 about?
NCT04496908 is a clinical study titled "Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)". This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. Women will be includ...
What is the current status of trial NCT04496908?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 160 participants. The study started on 2020-09-16. Estimated completion is 2021-10-18.
What interventions are being tested in trial NCT04496908?
The interventions under investigation include: Misoprostol (DRUG), Foley Catheter (DEVICE), amniotomy (PROCEDURE).
Who is sponsoring clinical trial NCT04496908?
This trial is sponsored by Christiana Care Health Services, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04496908's enrollment target sits among peer trials
160 88th of 2000 higher than 1,906 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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