Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy (SOFT)
May 17, 2017 updated by: Loyola University
Study of Obstetric Foley Therapy (SOFT Trial)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
139
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
intermittent straight catheterization will be performed on an as needed basis until time of delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Delivery (by Any Route)
Time Frame: 1 day
|
Time to delivery defined as IV placement to delivery of infant.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
End of study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarita Massey, MD, Loyola University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
August 14, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimate)
August 17, 2009
Study Record Updates
Last Update Posted (Actual)
May 19, 2017
Last Update Submitted That Met QC Criteria
May 17, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.