a Smptomatic Bacteriuria in Pregnancy

a Symptomatic Bacteriuria in Pregnant Females

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

Study Overview

• Status: Unknown
• Conditions: Bacteriuria in Pregnancy
• Intervention / Treatment: Diagnostic test: urine analysis

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 Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

• Study Contact: Name: Mahmoud Alalfy, M.s.c; Phone Number: 01002611058; Email: mahmoudalalfy@ymail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Algazeerah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant non-symptomatic females.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pregnant women in first Trimester; A urine sample will be taken from pregnant women before 14 weeks of pregnancy	Diagnostic test: urine analysis; 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	Diagnostic test: urine analysis; 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	Diagnostic test: urine analysis; Intervention is (urine analysis ): of a mid stream urine sample will be taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who will discovered to have bacteriuria	Incidence of asymptomatic bacteriuria among pregnant females.	within 4 weeks

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): July 15, 2019

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: A symptomatic bacteriuria

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research will be published after finishing results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No