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Catheterization During Second Elective Caesarean Delivery (CDSECD)

Primary Purpose

Wound Infection

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Foley's Catheter
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring CCSWI

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • AinShamsURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1

Group 2

Arm Description

Use of urinary catheterization in Cesarean section

NO urinary catheterization during Cesarean section

Outcomes

Primary Outcome Measures

Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field

Secondary Outcome Measures

Full Information

First Posted
May 6, 2014
Last Updated
May 16, 2014
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02143089
Brief Title
Catheterization During Second Elective Caesarean Delivery
Acronym
CDSECD
Official Title
Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
CCSWI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Use of urinary catheterization in Cesarean section
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
NO urinary catheterization during Cesarean section
Intervention Type
Device
Intervention Name(s)
Foley's Catheter
Intervention Description
Urinary tract infection inpatient catheterized versus non catheterized
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Helmy, Master
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AinShamsU
City
Cairo
ZIP/Postal Code
+20
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Helmy, Master
Phone
01227900014
First Name & Middle Initial & Last Name & Degree
Amr Helmy, Master

12. IPD Sharing Statement

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Catheterization During Second Elective Caesarean Delivery

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