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NCT00383942 · ClinicalTrials.gov registry record · Phase 4
Ripening Interventions: Prostaglandins vs EASI Catheter
A Phase 4 study, sponsored by Loyola University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT00383942: Clinical Trial Phase 4 study, sponsored by Loyola University.
NCT00383942 is a Phase 4 study that was terminated before completion, run by Loyola University. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00383942, a Phase 4 study, was terminated before completion, sponsored by Loyola University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.
Primary Outcome
The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.
Interventions
- DRUG Misoprostol
- DEVICE Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-08-31 |
| Est. Completion | 2008-06-18 |
| Phase | Phase 4 |
Why NCT00383942 stopped before completion
NCT00383942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Misoprostol is the first listed.
NCT00383942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00383942 about?
NCT00383942 is a clinical study titled "Ripening Interventions: Prostaglandins vs EASI Catheter". The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypo...
What is the current status of trial NCT00383942?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2006-08-31. Estimated completion is 2008-06-18.
What interventions are being tested in trial NCT00383942?
The interventions under investigation include: Misoprostol (DRUG), Catheter (DEVICE).
Who is sponsoring clinical trial NCT00383942?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00383942's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 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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