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NCT03039036 · ClinicalTrials.gov registry record · NA
Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
NCT03039036: Completed NA study, sponsored by Northwestern University.
NCT03039036 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03039036, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
Study Summary
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score \<7 at 5 minutes, neonatal need for intensive care. The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.
Primary Outcome
Hours
Interventions
- DRUG Misoprostol
- DEVICE Foley Catheter
- PROCEDURE Amniotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2017-09-12 |
| Est. Completion | 2022-12-01 |
| Phase | NA |
What the finished NCT03039036 record still lists
NCT03039036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Misoprostol is the first listed.
NCT03039036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03039036 about?
NCT03039036 is a clinical study titled "Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction". Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing earl...
What is the current status of trial NCT03039036?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2017-09-12. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT03039036?
The interventions under investigation include: Misoprostol (DRUG), Foley Catheter (DEVICE), Amniotomy (PROCEDURE).
Who is sponsoring clinical trial NCT03039036?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03039036's enrollment target sits among peer trials
69 1133rd of 2000 higher than 868 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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