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

Loyola University

Status: Completed

Conditions: Labor

Treatments: Procedure: Intermittent straight catheterization; Procedure: Indwelling catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00959920

201539

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Indwelling foley catheter

Active Comparator group

Description:

Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.

Treatment:

Procedure: Indwelling catheter

Intermittent straight catheterization

Active Comparator group

Description:

Intermittent straight catheterization will be performed as needed during labor.

Treatment:

Procedure: Intermittent straight catheterization