Clinical trial NCT06242756: Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Official title: A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Keywords: cesarean section
bladder catheterization
foley
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time at readiness for discharge post-surgery
timeFrame: Prior to discharge, average of 2 days postpartum
measure: Time to ambulation
timeFrame: Prior to discharge, an average of 2 days postpartum
Secondary outcomes:
measure: Incidence of urinary retention
timeFrame: Prior to discharge, an average of 2 days postpartum
measure: Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
timeFrame: first 4 weeks postpartum
measure: Incidence of bladder injury in surgery
timeFrame: During surgery
measure: Operating time
timeFrame: During surgery
measure: Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
timeFrame: Prior to discharge, an average of 2 days postpartum
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stephen L. Wood, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: