NCT00959920

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

Study of Obstetric Foley Therapy (SOFT Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor

Interventions

Type	Name	Description
PROCEDURE	Indwelling catheter	Indwelling bladder catheter will remain in place until time of delivery.
PROCEDURE	Intermittent straight catheterization	intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-08-17
• Last updated: 2017-05-19
• Results posted: 2012-05-23

Locations

1 site across 1 country: United States