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Study of Obstetric Foley Techniques (SOFT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00959920
First received: August 14, 2009
Last updated: April 24, 2012
Last verified: April 2012
History of Changes

August 14, 2009
April 24, 2012
July 2009
December 2009   (final data collection date for primary outcome measure)
Time to Delivery (by Any Route) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Time to delivery defined as IV placement to delivery of infant.
Time to delivery (by any route) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00959920 on ClinicalTrials.gov Archive Site
Difference in Cost Between the Two Interventions: Intermittent vs. Foley Catheterization. [ Time Frame: End of study. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Obstetric Foley Techniques
Study of Obstetric Foley Therapy (SOFT Trial)

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 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Labor
  • Procedure: Indwelling catheter
    Indwelling bladder catheter will remain in place until time of delivery.
  • Procedure: Intermittent straight catheterization
    intermittent straight catheterization will be performed on an as needed basis until time of delivery.
  • 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.
    Intervention: Procedure: Indwelling catheter
  • Active Comparator: Intermittent straight catheterization
    Intermittent straight catheterization will be performed as needed during labor.
    Intervention: Procedure: Intermittent straight catheterization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00959920
201539
Yes
Loyola University
Loyola University
Not Provided
Principal Investigator: Sarita Massey, MD Loyola University
Loyola University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP