Clinical Trials Directory

Trials / Completed

CompletedNCT06242756

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University of Calgary · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBladder catheterizationPatients 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.

Timeline

Start date
2024-08-27
Primary completion
2026-02-18
Completion
2026-02-18
First posted
2024-02-05
Last updated
2026-03-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06242756. Inclusion in this directory is not an endorsement.