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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959920
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : May 23, 2012
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Labor Procedure: Indwelling catheter Procedure: Intermittent straight catheterization Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Obstetric Foley Therapy (SOFT Trial)
Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: Indwelling foley catheter
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
Indwelling bladder catheter will remain in place until time of delivery.
Active Comparator: Intermittent straight catheterization
Intermittent straight catheterization will be performed as needed during labor.
Procedure: Intermittent straight catheterization
intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Primary Outcome Measures :
  1. Time to Delivery (by Any Route) [ Time Frame: 1 day ]
    Time to delivery defined as IV placement to delivery of infant.

Secondary Outcome Measures :
  1. Difference in Cost Between the Two Interventions [ Time Frame: End of study. ]
    Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959920

United States, Illinois
Loyola University Health System
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Principal Investigator: Sarita Massey, MD Loyola University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Loyola University Identifier: NCT00959920     History of Changes
Other Study ID Numbers: 201539
First Posted: August 17, 2009    Key Record Dates
Results First Posted: May 23, 2012
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Loyola University:
Indwelling bladder catheter
Intermittent straight catheterization
Labor and Delivery
Time to delivery during labor