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NCT02639429 · ClinicalTrials.gov registry record · Phase 4
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 236
- Enrollment target
NCT02639429: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT02639429 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 236 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02639429, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 236 participants
- Enrollment target
Study Summary
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
Interventions
- DRUG Vaginal Misoprostol
- DEVICE Foley Balloon + Vaginal Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-06-24 |
| Phase | Phase 4 |
What the finished NCT02639429 record still lists
NCT02639429 is an interventional study that assigns participants to a tested intervention. The registered 236 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 (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Vaginal Misoprostol is the first listed.
NCT02639429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02639429 about?
NCT02639429 is a clinical study titled "Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial". Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obes...
What is the current status of trial NCT02639429?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 236 participants. The study started on 2016-01. Estimated completion is 2018-06-24.
What interventions are being tested in trial NCT02639429?
The interventions under investigation include: Vaginal Misoprostol (DRUG), Foley Balloon + Vaginal Misoprostol (DEVICE).
Who is sponsoring clinical trial NCT02639429?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02639429's enrollment target sits among peer trials
236 367th of 2000 higher than 1,632 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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