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NCT04028765 · ClinicalTrials.gov registry record · Phase 4
Pitocin or Oral Misoprostol for PROM IOL
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
NCT04028765: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT04028765 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 108 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04028765, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
Study Summary
Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is not known, particularly among specific subpopulations. The primary aim of this study is to determine if oxytocin (Pitocin) or oral misoprostol results in a shorter interval to delivery after the start of induction among nulliparous women with unfavorable cervical exams with term PROM.
Primary Outcome
Time (hours) from start of IOL (As defined by receipt of first medication for induction of labor) to delivery of infant.
Interventions
- DRUG Oxytocin
- DRUG Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2023-01-08 |
| Phase | Phase 4 |
What the finished NCT04028765 record still lists
NCT04028765 is an interventional study that assigns participants to a tested intervention. The registered 108 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxytocin is the first listed.
NCT04028765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04028765 about?
NCT04028765 is a clinical study titled "Pitocin or Oral Misoprostol for PROM IOL". Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term. A delay from PROM to labor is associated with an increased risk of intrauterine infection and associated maternal and fetal morbidity; therefore, induction of labor (IOL) is recommended. The ideal agent for IOL is n...
What is the current status of trial NCT04028765?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2019-08-12. Estimated completion is 2023-01-08.
What interventions are being tested in trial NCT04028765?
The interventions under investigation include: Oxytocin (DRUG), Misoprostol (DRUG).
Who is sponsoring clinical trial NCT04028765?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04028765's enrollment target sits among peer trials
108 740th of 2000 higher than 1,256 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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