Cesarean Section Complications
Conditions
Keywords
cesarean section, bladder catheterization, foley
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.
Interventions
PROCEDUREBladder 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.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time at readiness for discharge post-surgery | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urinary retention | Prior to discharge, an average of 2 days postpartum | 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 |
| Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum | first 4 weeks postpartum | Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum |
| Incidence of bladder injury in surgery | During surgery | Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
| Operating time | During surgery | Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
| Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS) | Prior to discharge, an average of 2 days postpartum | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORStephen L. Wood, MD, MSc
University of Calgary
Outcome results
None listed