Comparison of Immediate Versus Delayed Removal of Urinary... | NCT02074852

Studies
Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section

NCT02074852

Sponsor

Akmal El-Mazny

Status

Completed

Last Update Posted

Mar 4, 2014Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Urinary Catheter
Cesarean Section
Urinary Infection

Interventions

Foley urethral 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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 28, 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

Mar 1, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate catheter removal		The catheter was removed immediately after the CS	Other: Foley urethral catheter
Delayed catheter removal		The catheter was removed 12 hours postoperatively	Other: Foley urethral catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Foley urethral catheter	Other		Delayed catheter removal Immediate catheter removal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of cases with significant bacteriuria and urinary symptoms		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women admitted to the prenatal wards for primary or repeat elective cesarean section

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided