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NCT02098421 · ClinicalTrials.gov registry record · Phase 1
Foley Labor Induction Trial at Term and in PROM
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 312
- Enrollment target
NCT02098421: Completed Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02098421 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 312 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (420% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02098421, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 312 participants
- Enrollment target
Study Summary
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia. Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed. After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
Primary Outcome
The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
Interventions
- DRUG Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-04-18 |
| Phase | Phase 1 |
What the finished NCT02098421 record still lists
NCT02098421 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (420% higher).
The record links to 0 conditions, and to 1 intervention - of which Oxytocin is the first listed.
NCT02098421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02098421 about?
NCT02098421 is a clinical study titled "Foley Labor Induction Trial at Term and in PROM". This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal ou...
What is the current status of trial NCT02098421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 312 participants. The study started on 2014-11. Estimated completion is 2016-04-18.
What interventions are being tested in trial NCT02098421?
The interventions under investigation include: Oxytocin (DRUG).
Who is sponsoring clinical trial NCT02098421?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02098421's enrollment target sits among peer trials
312 119th of 2000 higher than 1,881 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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