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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02074852
Other study ID # urinary catheter following CS
Secondary ID
Status Completed
Phase N/A
First received February 24, 2014
Last updated March 1, 2014
Start date November 2012

Study information

Verified date March 2014
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health and Population
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Intervention

Other:
Foley urethral catheter


Locations

Country Name City State
Egypt Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Akmal El-Mazny

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of cases with significant bacteriuria and urinary symptoms 1 year No
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