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NCT01916681 · ClinicalTrials.gov registry record · NA
Foley OR MisO for the Management of Induction
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 491
- Enrollment target
NCT01916681: Completed NA study, sponsored by University of Pennsylvania.
NCT01916681 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 491 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01916681, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 491 participants
- Enrollment target
Study Summary
The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.
Interventions
- DEVICE Cervical Foley & Misoprostol
- DRUG Misoprostol Alone
- DEVICE Cervical Foley Alone
- DEVICE Cervical Foley & Pitocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01916681
The ClinicalTrials.gov registry entry for NCT01916681 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cervical Foley & Misoprostol is the first listed.
NCT01916681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01916681 about?
NCT01916681 is a clinical study titled "Foley OR MisO for the Management of Induction". The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL...
What is the current status of trial NCT01916681?
This trial is currently completed. It is a NA study. The enrollment target is 491 participants. The study started on 2013-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01916681?
The interventions under investigation include: Cervical Foley & Misoprostol (DEVICE), Misoprostol Alone (DRUG), Cervical Foley Alone (DEVICE), Cervical Foley & Pitocin (DEVICE).
Who is sponsoring clinical trial NCT01916681?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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