Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

a Smptomatic Bacteriuria in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499561
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Kasr El Aini Hospital
Information provided by (Responsible Party):
Mahmoud Alalfy, 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

Condition or disease Intervention/treatment
Bacteriuria in Pregnancy 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%)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: a Symptomatic Bacteriuria in Pregnant Females
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The number of participants who will discovered to have bacteriuria [ Time Frame: within 4 weeks ]
    Incidence of asymptomatic bacteriuria among pregnant females.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females with no symptoms
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant non-symptomatic females.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499561


Contacts
Layout table for location contacts
Contact: Mahmoud Alalfy, M.s.c 01002611058 mahmoudalalfy@ymail.com

Locations
Layout table for location information
Egypt
Algazeerah Recruiting
Giza, Egypt
Contact: Mahmoud Alalfy, master    +201002611058    mahmoudalalfy@ymail.com   
Contact: Ahmed Elgazzar, M.D    +201014005959      
Principal Investigator: Mahmoud Alalfy, master         
Sponsors and Collaborators
Aljazeera Hospital
Kasr El Aini Hospital
Investigators
Layout table for investigator information
Principal Investigator: Mahmoud Alalfy Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Layout table for additonal information
Responsible Party: Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03499561    
Other Study ID Numbers: A symptomatic bacteriuria
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research will be published after finishing results

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases