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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder catheterization | Experimental | 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. |
|
| Non-use of bladder catheterization | No Intervention | Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder catheterization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Stephen L. Wood, MD, MSc | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2024 | Mar 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| ID | Term |
|---|---|
| D003950 | Diagnostic Techniques, Urological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002404 | Catheterization |
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Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum |
| 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. | During surgery |
| Operating time | Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. | During surgery |
| 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 |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |