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

A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: Bladder catheterization

Detailed Description

This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen L. Wood, MD, MSc; Phone Number: 403-944-1438; Email: stephen.wood@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bladder catheterization; 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; 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.
No Intervention: Non-use of bladder catheterization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urinary retention	Urinary retention will be defined based on a patient's inability to spontaneously void requiring either in-and-out catheterization or placement of an indwelling catheter during the post operative course	Prior to discharge, an average of 2 days postpartum
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks 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	Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.	During surgery
Operating time	Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.	During surgery
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)	Patients will be asked to complete the Maternal Satisfaction for Cesarean Section questionnaire at discharge. The minimum and maximum values are 7 and 154 and higher scores mean a better outcome.	Prior to discharge, an average of 2 days postpartum

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Stephen L. Wood, MD, MSc, University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cesarean section; foley; bladder catheterization
• Other Study ID Numbers: REB24-0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No