Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
Completed · Phase 4
Conditions studied: Induction of Labor
In brief
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.
Key facts
- Study ID
- NCT00451308
- Run by
- University of California, San Francisco
- People needed
- 192
- Starts
- 2006-11-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2013-08-02
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Reproductive aged women, pregnant, term gestation (>37 weeks), undergoing induction of labor, cervical exam acceptable as a candidate for Foley balloon catheter placement (Bishop score <5), cephalic fetal presentation.
You may not qualify if…
- Regular contractions on admission, rupture of membranes, previous uterine scar, low-lying placenta (measured <3cm to internal os), Bishop score > 5, contraindication to attempt at vaginal birth, non-English/Spanish speaking, unable to give consent.
Where it is running
- University of California, San Francisco Department of Obstetrics, Gynecology and Reproductive Sciences — San Francisco, California, United States
Full record on ClinicalTrials.gov
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