Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

Not Applicable

• Conditions: Urinary Retention; Cesarean Section Complications
• Interventions: Device: Urinary catheter

• Registration Number: NCT05396430
• Lead Sponsor: Women's Hospital HUS

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.

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-05-31
• Study Start: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urinary catheter 8 hours	Urinary catheter	The urinary cathter is to be removed at 8 hours after the end of surgery
Urinary catheter 12 hours	Urinary catheter	The urinary cathter is to be removed at 12 hours after the end of surgery
Urinary catheter 10 hours	Urinary catheter	The urinary cathter is to be removed at 10 hours after the end of surgery

Primary Outcome Measures

Name	Time	Method
Success of spontaneous voiding of bladder	6-12 hours after removal of the urinary catheter	Assessed by ultrasound bladder scanner after attempted voiding of the bladder

Secondary Outcome Measures

Name	Time	Method
Amount of residual urine in the bladder	6-12 hours after removal of the urinary catheter	Assessed by ultrasound
Need for standard in-house medications to help spontaneous voiding of the bladder	6-12 hours after removal of the urinary catheter	Amount of medicines given
Need for re-cathterization of the bladder	6-12 hours after removal of the urinary catheter

Trial Locations

Locations (1)

HUS/Women's hospital dept of obstetrics; 🇫🇮 Helsinki, Finland