Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy (SOFT)
|ClinicalTrials.gov Identifier: NCT00959920|
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : May 23, 2012
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Labor||Procedure: Indwelling catheter Procedure: Intermittent straight catheterization||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Time to Delivery (by Any Route) [ Time Frame: 1 day ]Time to delivery defined as IV placement to delivery of infant.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959920
|United States, Illinois|
|Loyola University Health System|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Sarita Massey, MD||Loyola University|