Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-01-19
Brief Title:
Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None