Clinical trial NCT04244526: Urinary Tract Infection in Pregnancy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Tract Infections
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at different trimesters with cystitis and pyelonephritis and asymptomatic bacteriuria

Brief summary: * 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of virulence genes in different isolated UPEC strains
timeFrame: Three months
Secondary outcomes:
measure: Correlation between the virulence genes and antibiotic resistance
timeFrame: Seven months
Other outcomes:
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