Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor. The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.

Official Title
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Study of Obstetric Foley Therapy (SOFT Trial)

Conditions
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Labor

Intervention / Treatment
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* Procedure: Indwelling catheter
* Procedure: Intermittent straight catheterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Indwelling foley catheter<br>Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery. | Procedure: Indwelling catheter<br>* Indwelling bladder catheter will remain in place until time of delivery.<br>|
| Active Comparator: Intermittent straight catheterization<br>Intermittent straight catheterization will be performed as needed during labor. | Procedure: Intermittent straight catheterization<br>* intermittent straight catheterization will be performed on an as needed basis until time of delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Delivery (by Any Route) | Time to delivery defined as IV placement to delivery of infant. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Cost Between the Two Interventions | Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars. | End of study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indwelling bladder catheter, Intermittent straight catheterization, Labor and Delivery, Time to delivery during labor