Back to resultsDuration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia
Primary Purpose
Urinary Retention, Cesarean Section Complications
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Urinary catheter
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention
Eligibility Criteria
Inclusion Criteria:
- After informed consent, signed the participation form (volunteered for the study)
- Cesarean section
- Spinal anesthesia
Exclusion Criteria:
- Prior neuraxial analgesia (epidural or spinal) for attempted labour
Sites / Locations
- HUS/Women's hospital dept of obstetrics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Urinary catheter 8 hours
Urinary catheter 10 hours
Urinary catheter 12 hours
Arm Description
The urinary cathter is to be removed at 8 hours after the end of surgery
The urinary cathter is to be removed at 10 hours after the end of surgery
The urinary cathter is to be removed at 12 hours after the end of surgery
Outcomes
Primary Outcome Measures
Success of spontaneous voiding of bladder
Assessed by ultrasound bladder scanner after attempted voiding of the bladder
Secondary Outcome Measures
Amount of residual urine in the bladder
Assessed by ultrasound
Need for standard in-house medications to help spontaneous voiding of the bladder
Amount of medicines given
Need for re-cathterization of the bladder
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05396430
Brief Title
Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia
Official Title
Early Recovery After Cesarean Delivery: Duration of Urinary Catheter Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's Hospital HUS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.
Detailed Description
In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Cesarean Section Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The parturients are randomized into 3 different treatment arms with different duration of planned urinary catheter treatment
Masking
None (Open Label)
Masking Description
Masking is not applicable, duration of urinary catheter treatment is decided at the time of surgery.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urinary catheter 8 hours
Arm Type
Experimental
Arm Description
The urinary cathter is to be removed at 8 hours after the end of surgery
Arm Title
Urinary catheter 10 hours
Arm Type
Experimental
Arm Description
The urinary cathter is to be removed at 10 hours after the end of surgery
Arm Title
Urinary catheter 12 hours
Arm Type
Active Comparator
Arm Description
The urinary cathter is to be removed at 12 hours after the end of surgery
Intervention Type
Device
Intervention Name(s)
Urinary catheter
Intervention Description
Duration of planned urinary cathterization following cesarean delivery
Primary Outcome Measure Information:
Title
Success of spontaneous voiding of bladder
Description
Assessed by ultrasound bladder scanner after attempted voiding of the bladder
Time Frame
6-12 hours after removal of the urinary catheter
Secondary Outcome Measure Information:
Title
Amount of residual urine in the bladder
Description
Assessed by ultrasound
Time Frame
6-12 hours after removal of the urinary catheter
Title
Need for standard in-house medications to help spontaneous voiding of the bladder
Description
Amount of medicines given
Time Frame
6-12 hours after removal of the urinary catheter
Title
Need for re-cathterization of the bladder
Time Frame
6-12 hours after removal of the urinary catheter
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
After informed consent, signed the participation form (volunteered for the study)
Cesarean section
Spinal anesthesia
Exclusion Criteria:
Prior neuraxial analgesia (epidural or spinal) for attempted labour
Facility Information:
Facility Name
HUS/Women's hospital dept of obstetrics
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia
We'll reach out to this number within 24 hrs