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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03499561
Other study ID # A symptomatic bacteriuria
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 17, 2018
Est. completion date July 15, 2019

Study information

Verified date January 2019
Source Aljazeera Hospital
Contact Mahmoud Alalfy, M.s.c
Phone 01002611058
Email mahmoudalalfy@ymail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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%)


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date July 15, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Algazeerah Giza

Sponsors (2)

Lead Sponsor Collaborator
Aljazeera Hospital Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants who will discovered to have bacteriuria Incidence of asymptomatic bacteriuria among pregnant females. within 4 weeks