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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
University of Calgary
Calgary, Alberta, Canada
RECRUITINGTime 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.
Time frame: Prior to discharge, average of 2 days postpartum
Time to ambulation
Time to ambulation will be collected via a form that will be distributed to the postpartum nursing team.
Time frame: Prior to discharge, an average of 2 days postpartum
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
Time frame: Prior to discharge, an average of 2 days postpartum
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
Time frame: first 4 weeks postpartum
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.
Time frame: During surgery
Operating time
Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon.
Time frame: During surgery
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
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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.
Time frame: Prior to discharge, an average of 2 days postpartum