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

University of Calgary

Status: Enrolling

Conditions: Cesarean Section Complications

Treatments: Procedure: Bladder catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT06242756

REB24-0044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Bladder catheterization

Experimental group

Description:

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.

Treatment:

Procedure: Bladder catheterization

Non-use of bladder catheterization

No Intervention group

Description:

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.