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

Labor Clinical Trial

— SOFT  

Official title:

Study of Obstetric Foley Therapy (SOFT Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959920
• Other study ID #: 201539
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: May 17, 2017
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2017
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor

Intervention

Procedure:
• Indwelling catheter
Indwelling bladder catheter will remain in place until time of delivery.
• Intermittent straight catheterization
intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Locations

Country	Name	City	State
United States	Loyola University Health System	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Delivery (by Any Route)	Time to delivery defined as IV placement to delivery of infant.	1 day
Secondary	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.