A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cesarean Section Complications
- Sponsor
- University of Calgary
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Time at readiness for discharge post-surgery
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time at readiness for discharge post-surgery
Time Frame: Prior 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 ambulation
Time Frame: Prior 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 Outcomes
- Operating time(During surgery)
- Incidence of bladder injury in surgery(During surgery)
- Incidence of urinary retention(Prior to discharge, an average of 2 days postpartum)
- Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum(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)