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NCT02143089 Clinical Trial

Catheterization During Second Elective Caesarean Delivery

Wound Infection Clinical Trial

— CDSECD  

Official title:
Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02143089
Other study ID # HSM28-10-12
Secondary ID
Status Recruiting
Phase N/A
First received May 6, 2014
Last updated May 16, 2014
Start date August 2013
Est. completion date September 2014

Study information
Verified date May 2014
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health and Population
Study type Interventional

Clinical Trial Summary

Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Description:

Evaluation OF use versus non use of urinary catheterization during Second Elective caesarean delivery:by urine analysis 24 hours postoperative to exclude urinary tract infection.

Recruitment information / eligibility
Status Recruiting
Enrollment 220
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 38 Years
Eligibility inclusion criteria

- pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age).

Exclusion Criteria:

- Women with history of more than one previous caesarean Section.

- Women with history of a tonic postpartum hemorrhage.

- Women with Urinary tract infection in present pregnancy.

- Women with diabetes mellitus in present pregnancy.

- Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy.

- Emergency caesarean section

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Foley's Catheter
Urinary tract infection inpatient catheterized versus non catheterized

Locations
Country Name City State
Egypt AinShamsU Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field participants will be followed for the duration of urinary tract infection,an expected average 2 days. Yes
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