- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074852
Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section
March 1, 2014 updated by: Akmal El-Mazny
The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
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
-
-
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Cairo, Egypt
- Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University
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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
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women admitted to the prenatal wards for primary or repeat elective cesarean section
Description
Inclusion Criteria:
- Women admitted to the prenatal wards for primary or repeat elective cesarean section
Exclusion Criteria:
- urinary infection (assessed clinically and by midstream urinalysis),
- significant vaginal bleeding,
- severe pre-eclampsia or eclampsia and/or any other conditions requiring postoperative monitoring of urinary output, and
- contraindications for general anesthesia.
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Immediate catheter removal
The catheter was removed immediately after the CS
|
|
Delayed catheter removal
The catheter was removed 12 hours postoperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of cases with significant bacteriuria and urinary symptoms
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 24, 2014
First Submitted That Met QC Criteria
February 25, 2014
First Posted (Estimate)
February 28, 2014
Study Record Updates
Last Update Posted (Estimate)
March 4, 2014
Last Update Submitted That Met QC Criteria
March 1, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- urinary catheter following CS
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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