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NCT03670836 · ClinicalTrials.gov registry record · Phase 4
Comparison of Misoprostol Ripening Efficacy With Dilapan
A Phase 4 study of Induced; Birth and Labor Onset and Length Abnormalities, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 307
- Enrollment target
- 2
- Study locations
NCT03670836: Completed Phase 4 study of Induced; Birth and Labor Onset and Length Abnormalities, sponsored by Columbia University.
NCT03670836 is a Phase 4 study of Induced; Birth and Labor Onset and Length Abnormalities that has completed, run by Columbia University. The registered enrollment target is 307 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03670836, a Phase 4 study of Induced; Birth and Labor Onset and Length Abnormalities, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 307 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.
Primary Outcome
This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening. Intent-to-treat Population (ITT) includes all patients that were randomized into the study. ITT participants will be analyzed in accordance with their randomized study treatment (i.e. in the treatment group they were originally allocated, regardless of treatment actually received). ITT will be used for evaluation of the baseline characteristics and as the primary population for efficacy assessments.
Conditions Studied
Interventions
- DRUG Misoprostol
- DEVICE Dilapan
Study Locations (2)
New York
- New York Presbyterian - Allen Hospital - New York
Texas
- University of Texas - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2021-07-21 |
| Phase | Phase 4 |
What the finished NCT03670836 record still lists
NCT03670836 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Induced; Birth appearing as the primary indexed condition, and to 2 interventions - of which Misoprostol is the first listed.
NCT03670836 reports a single indexed study location in New York, Texas.
Frequently Asked Questions
What is clinical trial NCT03670836 about?
NCT03670836 is a clinical study titled "Comparison of Misoprostol Ripening Efficacy With Dilapan". The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in ...
What is the current status of trial NCT03670836?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 307 participants. The study started on 2018-11-15. Estimated completion is 2021-07-21.
What conditions does trial NCT03670836 study?
This clinical trial studies the following conditions: Induced; Birth, Labor Onset and Length Abnormalities.
What interventions are being tested in trial NCT03670836?
The interventions under investigation include: Misoprostol (DRUG), Dilapan (DEVICE).
Who is sponsoring clinical trial NCT03670836?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03670836 being conducted?
This trial has 2 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03670836's enrollment target sits among peer trials
307 263rd of 2000 higher than 1,738 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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