Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

NCT05396430 | Unknown

• 1 other identifier: Tutkimussuunnitelma25032022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Success of spontaneous voiding of bladder

  Assessed by ultrasound bladder scanner after attempted voiding of the bladder

  6-12 hours after removal of the urinary catheter

Secondary Outcomes (3)

• Amount of residual urine in the bladder

  6-12 hours after removal of the urinary catheter

• Need for standard in-house medications to help spontaneous voiding of the bladder

  6-12 hours after removal of the urinary catheter

• Need for re-cathterization of the bladder

  6-12 hours after removal of the urinary catheter

Study Arms (3)

Urinary catheter 8 hours

EXPERIMENTAL

The urinary cathter is to be removed at 8 hours after the end of surgery

Device: Urinary catheter

Urinary catheter 10 hours

EXPERIMENTAL

The urinary cathter is to be removed at 10 hours after the end of surgery

Device: Urinary catheter

Urinary catheter 12 hours

ACTIVE COMPARATOR

The urinary cathter is to be removed at 12 hours after the end of surgery

Device: Urinary catheter

Interventions

Urinary catheter DEVICE

Duration of planned urinary cathterization following cesarean delivery

Urinary catheter 10 hours; Urinary catheter 12 hours; Urinary catheter 8 hours

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• After informed consent, signed the participation form (volunteered for the study)
• Cesarean section
• Spinal anesthesia

You may not qualify if:

• Prior neuraxial analgesia (epidural or spinal) for attempted labour

Sponsors & Collaborators

• Women's Hospital HUS: lead

Study Sites (1)

HUS/Women's hospital dept of obstetrics

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Urinary Catheters

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not applicable, duration of urinary catheter treatment is decided at the time of surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The parturients are randomized into 3 different treatment arms with different duration of planned urinary catheter treatment

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: May 31, 2022
• Study Start: January 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)