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Bladder catheterization for Cesarean Section Complications

N/A

Waitlist Available

Led By Stephen L. Wood, MD, MSc

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 4 weeks postpartum

Awards & highlights

Study Summary

This trial aims to study the effects of using a catheter in uncomplicated cesarean sections on how long patients stay in the hospital, how soon they can start moving around, the risk of urinary

Who is the study for?

This trial is for women aged 18 or older who are pregnant with one baby and scheduled for an elective first-time or repeat cesarean section (CS), without complications like abnormal placenta placement.Check my eligibility

What is being tested?

The study is testing if using a bladder catheter during elective CS affects the time to get ready for discharge, walking ability post-surgery, urinary issues, risk of bladder injury, surgery duration, and patient happiness.See study design

What are the potential side effects?

Potential side effects from bladder catheterization may include discomfort during insertion or removal, possible urinary tract infections, and in rare cases difficulty urinating after removal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18, pregnant with one baby, planning a first or repeat C-section.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to discharge, an average of 2 days postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to discharge, an average of 2 days postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to discharge, an average of 2 days postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time at readiness for discharge post-surgery

Time to ambulation

Secondary outcome measures

Incidence of bladder injury in surgery

Incidence of urinary retention

Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bladder catheterizationExperimental Treatment1 Intervention

Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section.

Group II: Non-use of bladder catheterizationActive Control1 Intervention

Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bladder catheterization

2015

N/A

~1080

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,014 Total Patients Enrolled

Stephen L. Wood, MD, MScPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"As per clinicaltrials.gov, this investigation is not presently seeking subjects. Originally shared on 2/1/2024 and last modified on 2/2/2024, the study remains inactive in terms of patient recruitment. Nonetheless, it's worth noting that there are currently 20 other trials actively enrolling participants."

Answered by AI

What are the objectives of this particular research endeavor?

"The aim of this examination, which will be supervised for approximately 48 hours after childbirth prior to release from medical care is to assess the period required before patients are ready for discharge following surgery. Additional outcomes involve the rate of urinary tract infections necessitating antibiotics within the initial 4 weeks post-delivery, surgical duration documented through a digital survey filled out by the surgeon conducting the operation, and patient contentment gauged using the Maternal Satisfaction for Cesarean Section questionnaire administered at hospital departure. Scores can range between 7 and 154 on this scale, with higher values indicating enhanced satisfaction levels."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery

2024. "Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242756.