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

Not Applicable
Not yet recruiting
Conditions
Cesarean Section Complications
Interventions
Procedure: Bladder catheterization
Registration Number
NCT06242756
Lead Sponsor
University of Calgary
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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
140
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Bladder catheterizationBladder 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.
Primary Outcome Measures
NameTimeMethod
Time at readiness for discharge post-surgeryPrior to discharge, average of 2 days postpartum

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

Time to ambulationPrior to discharge, an average of 2 days postpartum

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

Secondary Outcome Measures
NameTimeMethod
Incidence of bladder injury in surgeryDuring surgery

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

Operating timeDuring surgery

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

Incidence of urinary retentionPrior to discharge, an average of 2 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

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

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

Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)Prior to discharge, an average of 2 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.

Trial Locations

Locations (1)

University of Calgary

🇨🇦

Calgary, Alberta, Canada

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