Urinary Tract Infection in Pregnancy

Distribution of Virulence Genes and Their Association With Clinical Presentation of Urinary Tract Infection and Antimicrobial Resistance Among Uropathogenic Escherichia Coli Isolated From Pregnant Women

• to describe the profile of uropathogenic E coli from Egyptian pregnant women with UTIs and a symptomatic bacteriuria.
• to determine the susceptibility pattern of our local isolated UPEC strains which is essential for optimal management of UTI.
• to evaluate the different virulence genes in UPEC isolates and their association with antibiotic resistance.
• to track common UPEC serogroups.
• to investigate the biofilm formation and the relationship between virulence genes and biofilm formation in UPEC strains isolated from patients.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Other: Talking a urine sample

Detailed Description

Urinary tract infection represents the most common bacterial infection in pregnancy and the third common cause of human infection after respiratory and intestinal infections. The infection can be life threatening and associated with serious complications. UTI can be associated with defined symptoms'symptomatic' or without symptoms 'asymptomatic'. Asymptomatic bacteriuria is defined as the presence of >100000 colony forming units/ml of urine of a single pathogen in two consecutive midstream clean catch urine specimen or on catheterization specimen from an individual without signs or symptoms associated with urinary or genital organs. Asymptomatic bacteriuria can lead to acute pyelonephritis in30%of pregnant women and complications such as early delivery, increase risk of hypertension, pre-eclampsia, low birth weight and postpartum endometritis. Ecoli accounts for most cases of symptomatic and asymptomatic bacteriuria in women, representing70 _90 %of the cases. The important virulence factors of uropathogenic ecoli can be broadly divided into two groups :bacterial cell surface factors and secreted factors. The emergence of drug resistant microorganism among Uropathogenic Escherichia coli strains increases the serious threat to global health. Ecoli often acquired genes coding for antibiotic resistance, beta-lactamase enzymes are the most frequent and play a key role, conferring resistance of bacteria to beta lactam antibiotic group such as penicillin and cephalosporins. Therefore, knowledge regarding local prevalence of uropathogenic ecoli and antimicrobial resistance is essential for optimal management of UTI.

• Study Type: Observational
• Enrollment (Anticipated): 155

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at different trimesters with cystitis and pyelonephritis and asymptomatic bacteriuria

Description

Inclusion Criteria:

• pregnant women who diagnosed through clinical examination and urine analysis. 3 groups : group 1 pregnant women with cystitis Group 2 pregnant women with Pyelonephritis Group 3 pregnant women with asymptomatic bacteriuria

Exclusion Criteria:

• pregnant women on antibiotics _Patients with any anatomical abnormalities in the urinary tract

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1; Group 1:pregnant women with cystitis	Other: Talking a urine sample; Just taking a urine sample
Group2; Group 2: pregnant women with Pyelonephritis	Other: Talking a urine sample; Just taking a urine sample
Group3; Group 3: pregnant women with asymptomatic bacteriuria	Other: Talking a urine sample; Just taking a urine sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of virulence genes in different isolated UPEC strains	Measurment of virulence genes of Escherichia coli strains by molecular diagnosis as PCR technique to determine relationship between clinical presentation of urinary tract infection and distribution of virulence genes of strains	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the virulence genes and antibiotic resistance	Measurment of virulence genes of escherichia coli strains by molecular diagnosis as PCR technique,and determine antibiotic susceptibility of ecoli strains between different groups of women to determine relationship between distribution of virulence genea and antibiotic susceptibility of strains	Seven months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: January 25, 2020
• First Submitted That Met QC Criteria: January 25, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: Urinary Tract Infection

Drug and device information, study documents

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