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Completed

NCT Number: NCT06242756

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 time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time to ambulation

    Time frame: Prior to discharge, assessed up to 3 days postpartum

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

Secondary outcomes

  1. Incidence of urinary retention

    Time frame: Prior to discharge, assessed up to 3 days postpartum

    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

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

    Time frame: first 4 weeks postpartum

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

  3. Incidence of bladder injury in surgery

    Time frame: During surgery

    Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.

  4. Operating time

    Time frame: During surgery

    Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.

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

    Time frame: At discharge, assessed up to 3 days postpartum

    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.

  6. Time to discharge

    Time frame: At discharge, assessed up to 3 days postpartum

    Time to discharge; date and time of discharge will be collected during chart review

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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