a Smptomatic Bacteriuria in Pregnancy

• Conditions: Bacteriuria in Pregnancy
• Interventions: Diagnostic Test: urine analysis

• Registration Number: NCT03499561
• Lead Sponsor: Aljazeera Hospital

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

Detailed 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%)

Study Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-09
• Study Start: 2018-04-17
• Study First Posted: 2018-04-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Primary Completion: 2019-05-01
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women in second Trimester	urine analysis	A urine sample will be taken from pregnant women from 14 weeks +1 day till 28 weeks
pregnant women in third Trimester	urine analysis	A urine sample will be taken from pregnant women from 28 weeks +1 day till 40 weeks
pregnant women in first Trimester	urine analysis	A urine sample will be taken from pregnant women before 14 weeks of pregnancy

Primary Outcome Measures

Name	Time	Method
The number of participants who will discovered to have bacteriuria	within 4 weeks	Incidence of asymptomatic bacteriuria among pregnant females.

Trial Locations

Locations (1)

Algazeerah; 🇪🇬 Giza, Egypt