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
  Purpose

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.


Condition Intervention
Labor
Procedure: Indwelling catheter
Procedure: Intermittent straight catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Obstetric Foley Therapy (SOFT Trial)

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Difference in Cost Between the Two Interventions: Intermittent vs. Foley Catheterization. [ Time Frame: End of study. ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959920

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

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00959920     History of Changes
Other Study ID Numbers: 201539
Study First Received: August 14, 2009
Results First Received: April 24, 2012
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014