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NCT00451308 · ClinicalTrials.gov registry record · Phase 4
Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 192
- Enrollment target
NCT00451308: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT00451308 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 192 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00451308, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 192 participants
- Enrollment target
Study Summary
The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.
Interventions
- PROCEDURE Induction of labor with foley balloon - 60cc of saline
- PROCEDURE Induction of labor with foley balloon with 30cc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00451308 record still lists
NCT00451308 is an interventional study that assigns participants to a tested intervention. The registered 192 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 (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Induction of labor with foley balloon - 60cc of saline is the first listed.
NCT00451308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00451308 about?
NCT00451308 is a clinical study titled "Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml". The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter place...
What is the current status of trial NCT00451308?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 192 participants. The study started on 2006-11. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00451308?
The interventions under investigation include: Induction of labor with foley balloon - 60cc of saline (PROCEDURE), Induction of labor with foley balloon with 30cc (PROCEDURE).
Who is sponsoring clinical trial NCT00451308?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00451308's enrollment target sits among peer trials
192 451st of 2000 higher than 1,548 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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