Catheterization During Second Elective Caesarean Delivery | NCT02143089

Studies
Catheterization During Second Elective Caesarean Delivery

NCT02143089

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

May 20, 2014Estimated

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Wound Infection

Interventions

Foley's Catheter

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

May 6, 2014

First Submission Date that Met QC Criteria

May 16, 2014

First Posted Date

May 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2014

Last Update Posted Date

May 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Use of urinary catheterization in Cesarean section	Device: Foley's Catheter
Group 2	No Intervention	NO urinary catheterization during Cesarean section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Foley's Catheter	Device	Urinary tract infection inpatient catheterized versus non catheterized	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amr Helmy, Master	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShamsU	Recruiting	Cairo		+20	Egypt