Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery

NCT06242756 | Completed

• 1 other identifier: REB24-0044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on hospitalization time (readiness to discharge), time to ambulation, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.

Conditions

Cesarean Section Complications

Keywords

cesarean section; bladder catheterization; foley

Outcome Measures

Primary Outcomes (2)

• Time at readiness for discharge post-surgery

  Time at readiness for discharge post-surgery will be collected via a form that will be distributed to the postpartum nursing team.

  Prior to discharge, average of 2 days postpartum

• Time to ambulation

  Time to ambulation will be collected via a form that will be distributed to the postpartum nursing team.

  Prior to discharge, an average of 2 days postpartum

Secondary Outcomes (5)

• Incidence of urinary retention

  Prior to discharge, an average of 2 days postpartum

• Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum

  first 4 weeks postpartum

• Incidence of bladder injury in surgery

  During surgery

• Operating time

  During surgery

• Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)

  Prior to discharge, an average of 2 days postpartum

Study Arms (2)

Bladder catheterization

EXPERIMENTAL

Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section.

Procedure: Bladder catheterization

Non-use of bladder catheterization

NO INTERVENTION

Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter.

Interventions

Bladder catheterization PROCEDURE

Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section.

Bladder catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.

You may not qualify if:

• \- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Interventions

Urinary Catheterization

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Stephen L. Wood, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

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: January 19, 2024
• First Posted: February 5, 2024
• Study Start: August 27, 2024
• Primary Completion: February 18, 2026
• Study Completion: February 18, 2026
• Last Updated: March 2, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)