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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242756
• Other study ID #: REB24-0044
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Calgary
• Contact: Stephen L. Wood, MD, MSc
• Phone: 403-944-1438
• Email: stephen.wood[@]albertahealthservices.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• Bladder catheterization
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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time at readiness for discharge post-surgery	Time at readiness for discharge post-surgery will be collected via a form that will be distributed to the postpartum nursing team.	Prior to discharge, average of 2 days postpartum
Primary	Time to ambulation	Time to ambulation will be collected via a form that will be distributed to the postpartum nursing team.	Prior to discharge, an average of 2 days postpartum
Secondary	Incidence of urinary retention	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	Prior to discharge, an average of 2 days postpartum
Secondary	Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum	Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum	first 4 weeks postpartum
Secondary	Incidence of bladder injury in surgery	Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.	During surgery
Secondary	Operating time	Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.	During surgery
Secondary	Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)	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.	Prior to discharge, an average of 2 days postpartum