a Smptomatic Bacteriuria in Pregnancy

NCT ID: NCT03499561

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-07-15

Brief Summary

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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

Detailed Description

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ASB is common in women and increases in prevalence with age and/or sexual activity, due to short urethra, pregnancy, easy contamination of urinary tract with fecal flora

The pregnant women are two times more commonly affected than age matched non pregnant females. This is due to urinary stasis due to progesterone effect in pregnancy in addition to different morphological and physiological changes occurring during pregnancy The prevalence of ASB is about 3 times higher in diabetic women (ranging from 15% to 30%) than in non-diabetic women (less than 10%)

Conditions

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Bacteriuria in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnant women in first Trimester

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

urine analysis

Intervention Type DIAGNOSTIC_TEST

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

pregnant women in second Trimester

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

urine analysis

Intervention Type DIAGNOSTIC_TEST

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

pregnant women in third Trimester

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

urine analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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urine analysis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 1\. Pregnant females 2. Non-symptomatic females.

Exclusion Criteria

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

17 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Alalfy

Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Alalfy

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Algazeerah

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Alalfy, M.s.c

Role: CONTACT

01002611058

Facility Contacts

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Mahmoud Alalfy, master

Role: primary

+201002611058

Ahmed Elgazzar, M.D

Role: backup

+201014005959

Other Identifiers

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A symptomatic bacteriuria

Identifier Type: -

Identifier Source: org_study_id

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