Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

April 24, 2023 updated by: Antti Vaananen, Women's Hospital HUS

Early Recovery After Cesarean Delivery: Duration of Urinary Catheter Treatment

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • HUS/Women's hospital dept of obstetrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Urinary catheter 8 hours
The urinary cathter is to be removed at 8 hours after the end of surgery
Device: Urinary catheter
Duration of planned urinary cathterization following cesarean delivery
Experimental: Urinary catheter 10 hours
The urinary cathter is to be removed at 10 hours after the end of surgery
Device: Urinary catheter
Duration of planned urinary cathterization following cesarean delivery
Active Comparator: Urinary catheter 12 hours
The urinary cathter is to be removed at 12 hours after the end of surgery
Device: Urinary catheter
Duration of planned urinary cathterization following cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of spontaneous voiding of bladder
Time Frame: 6-12 hours after removal of the urinary catheter
Assessed by ultrasound bladder scanner after attempted voiding of the bladder
6-12 hours after removal of the urinary catheter

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital HUS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tutkimussuunnitelma25032022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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