NCT02074852

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

1.1 years

First QC Date

February 24, 2014

Last Update Submit

March 1, 2014

Conditions

Urinary CatheterCesarean SectionUrinary Infection

Outcome Measures

Primary Outcomes (1)

  • Number of cases with significant bacteriuria and urinary symptoms

    1 year

Study Arms (2)

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

Foley urethral catheterOTHER
Delayed catheter removalImmediate catheter removal

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass.Prof. , MD

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 28, 2014

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

EG(1)