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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 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 312 participants.
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).
Interventions
- DRUG Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-04-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02098421
The ClinicalTrials.gov registry entry for NCT02098421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxytocin is the first listed.
NCT02098421 reports 0 study locations.
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.
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