NCT03499561

Brief Summary

Asymptomatic bacteriuria (ASB) is defined as the presence of at least 105 colony-forming units (CFU)/ml of 1 or 2 bacterial species in clean-voided midstream urine sample from an individual without symptoms of UTI

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

April 6, 2018

Last Update Submit

January 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of participants who will discovered to have bacteriuria

    Incidence of asymptomatic bacteriuria among pregnant females.

    within 4 weeks

Study Arms (3)

pregnant women in first Trimester

A urine sample will be taken from pregnant women before 14 weeks of pregnancy

Diagnostic Test: urine analysis

pregnant women in second Trimester

A urine sample will be taken from pregnant women from 14 weeks +1 day till 28 weeks

Diagnostic Test: urine analysis

pregnant women in third Trimester

A urine sample will be taken from pregnant women from 28 weeks +1 day till 40 weeks

Diagnostic Test: urine analysis

Interventions

urine analysisDIAGNOSTIC_TEST

Intervention is (urine analysis ): of a mid stream urine sample will be taken

pregnant women in first Trimesterpregnant women in second Trimesterpregnant women in third Trimester

Eligibility Criteria

Age17 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females with no symptoms
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant non-symptomatic females.

You may qualify if:

  • \. Pregnant females 2. Non-symptomatic females.

You may not qualify if:

  • \. Patients taking antibiotics in the last two weeks. 2. Symptomatic UTI. 3. Suspected urinary tract abnormalities. 4. Urinary catheterization. 5. Renal dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Urinalysis

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative Techniques

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy, M.s.c

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 17, 2018

Study Start

April 17, 2018

Primary Completion

May 1, 2019

Study Completion

July 15, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

The research will be published after finishing results

Locations