- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02143089
Catheterization During Second Elective Caesarean Delivery (CDSECD)
May 16, 2014 updated by: Salwa Said Ali Wahba, Ain Shams University
Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery
Use versus non use of urinary catheterization during Second Elective caesarean delivery:
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Not Applicable
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
-
-
-
Cairo, Egypt, +20
- Recruiting
- AinShamsU
-
Contact:
- Amr Helmy, Master
- Phone Number: 01227900014
-
Principal Investigator:
- Amr Helmy, Master
-
-
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 38 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Use of urinary catheterization in Cesarean section
|
Urinary tract infection inpatient catheterized versus non catheterized
|
|
No Intervention: Group 2
NO urinary catheterization during Cesarean section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field
Time Frame: participants will be followed for the duration of urinary tract infection,an expected average 2 days.
|
participants will be followed for the duration of urinary tract infection,an expected average 2 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amr Helmy, Master, Ain Shams University
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
August 1, 2013
Primary Completion (Anticipated)
August 1, 2014
Study Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
May 6, 2014
First Submitted That Met QC Criteria
May 16, 2014
First Posted (Estimate)
May 20, 2014
Study Record Updates
Last Update Posted (Estimate)
May 20, 2014
Last Update Submitted That Met QC Criteria
May 16, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSM28-10-12
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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