N/A
N=139
Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy
Labor
Bottom Line
View on ClinicalTrials.gov: NCT00959920 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Time to Delivery (by Any Route) — 10.43; 11.23 Hours — p=.42
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indwelling catheter (Procedure); Intermittent straight catheterization (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Loyola University
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Delivery (by Any Route) |
10.43; 11.23 | .42 |
| SECONDARY Difference in Cost Between the Two Interventions |
— | — |
Summary
The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.
Eligibility Criteria
Inclusion Criteria
- Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission
Exclusion Criteria
- Women who are undergoing a scheduled cesarean delivery
- Women with a contraindication to either of the 2 study interventions
- Multi-fetal gestations
- Current or planned tocolysis
- Women who are on magnesium prophylaxis
Data sourced from ClinicalTrials.gov (NCT00959920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.