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

Not Applicable

Completed

• Conditions: Labor
• Interventions: Procedure: Indwelling catheter; Procedure: Intermittent straight catheterization

• Registration Number: NCT00959920
• Lead Sponsor: Loyola University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2012-04-24
• Results First Submitted QC: 2012-04-24
• Results First Posted: 2012-05-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indwelling foley catheter	Indwelling catheter	Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
Intermittent straight catheterization	Intermittent straight catheterization	Intermittent straight catheterization will be performed as needed during labor.

Primary Outcome Measures

Name	Time	Method
Time to Delivery (by Any Route)	1 day	Time to delivery defined as IV placement to delivery of infant.

Secondary Outcome Measures

Name	Time	Method
Difference in Cost Between the Two Interventions	End of study.	Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.

Trial Locations

Locations (1)

Loyola University Health System; 🇺🇸 Maywood, Illinois, United States