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

NCT00959920 | Completed Results DMC

• 1 other identifier: 201539
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor

Keywords

Indwelling bladder catheter; Intermittent straight catheterization; Labor and Delivery; Time to delivery during labor

Outcome Measures

Primary Outcomes (1)

• Time to Delivery (by Any Route)

  Time to delivery defined as IV placement to delivery of infant.

  1 day

Secondary Outcomes (1)

• Difference in Cost Between the Two Interventions

  End of study.

Study Arms (2)

Indwelling foley catheter

ACTIVE COMPARATOR

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

Intermittent straight catheterization

ACTIVE COMPARATOR

Intermittent straight catheterization will be performed as needed during labor.

Procedure: Intermittent straight catheterization

Interventions

Indwelling catheter PROCEDURE

Indwelling bladder catheter will remain in place until time of delivery.

Indwelling foley catheter

Intermittent straight catheterization PROCEDURE

intermittent straight catheterization will be performed on an as needed basis until time of delivery.

Intermittent straight catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

Related Publications (1)

• Rivard C, Awad M, Liebermann M, Dejong M, Massey SM, Sinacore J, Brubaker L. Bladder drainage during labor: a randomized controlled trial. J Obstet Gynaecol Res. 2012 Aug;38(8):1046-51. doi: 10.1111/j.1447-0756.2011.01837.x. Epub 2012 Apr 30.

  PMID: 22540248 DERIVED

MeSH Terms

Interventions

Catheters, Indwelling

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Limitations and Caveats

The are not limitations or caveats to disclose.

Results Point of Contact

• Title: Dr. Sarita Massey
• Organization: Loyola University Medical Center

smassey@lumc.edu

708-354-9250

Study Officials

• Sarita Massey, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 19, 2017
• Results First Posted: May 23, 2012

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)