Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section
Sponsor
Akmal El-Mazny (Other)
Overall Status
Completed
CT.gov ID
NCT02074852
Collaborator
(none)
300
1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
300 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Study Start Date
:
Nov 1, 2012
Actual Primary Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Immediate catheter removal The catheter was removed immediately after the CS |
Other: Foley urethral catheter
|
| Delayed catheter removal The catheter was removed 12 hours postoperatively |
Other: Foley urethral catheter
|
Outcome Measures
Primary Outcome Measures
- Number of cases with significant bacteriuria and urinary symptoms [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University | Cairo | Egypt |
Sponsors and Collaborators
- Akmal El-Mazny
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Akmal El-Mazny,
Ass.Prof. , MD,
Cairo University
ClinicalTrials.gov Identifier:
NCT02074852
Other Study ID Numbers:
- urinary catheter following CS
First Posted:
Feb 28, 2014
Last Update Posted:
Mar 4, 2014
Last Verified:
Mar 1, 2014
Additional relevant MeSH terms: