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Status unknownNCT03499561Updated Jan 9, 2019

a Smptomatic Bacteriuria in Pregnancy

An observational study in Bacteriuria in Pregnancy, sponsored by Aljazeera Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 17 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Aljazeera Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
17 Years to 40 Years
Sex
Female
01

Study 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

Read the 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%)

02

Conditions studied

  • Bacteriuria in Pregnancy

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03

Who can participate

Ages eligible
17 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnant non-symptomatic females.

Inclusion criteria

    1. Pregnant females 2. Non-symptomatic females.

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (estimated)
Patient registry
No

Groups and cohorts

  • pregnant women in first Trimester

    A urine sample will be taken from pregnant women before 14 weeks of pregnancy

    Diagnostic Test: urine analysis

  • 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

  • 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

Interventions

  • Diagnostic testurine analysis

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

05

What researchers measure

Primary outcomes

  1. The number of participants who will discovered to have bacteriuria

    Incidence of asymptomatic bacteriuria among pregnant females.

    Time frame: within 4 weeks

06

Study locations

1 of 1 sites recruiting
  • Algazeerah
    Giza, Egypt
    • Mahmoud Alalfy, master · Contact · mahmoudalalfy@ymail.com · +201002611058
    • Ahmed Elgazzar, M.D · Contact · +201014005959
    • Mahmoud Alalfy, master · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — The research will be published after finishing results

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03499561
Lead sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital
Responsible party
Mahmoud Alalfy (Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital) — Principal investigator
First posted
Apr 17, 2018
Start date
Apr 17, 2018
Primary completion
May 1, 2019 (estimated)
Completion
Jul 15, 2019 (estimated)
Last update
Jan 9, 2019

Study contacts

Mahmoud Alalfy, M.s.c
Contact
mahmoudalalfy@ymail.com
01002611058
Mahmoud Alalfy
principal investigator · Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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