Bacteriuria in PregnancyNCT03499561
a Smptomatic Bacteriuria in Pregnancy
An observational study of Bacteriuria in Pregnancy, run by Aljazeera Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacteriuria in Pregnancy
- What is being tested?
- urine analysis
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Apr 2018to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant non-symptomatic females.
Who may be able to join
- 1. Pregnant females 2. Non-symptomatic females.
Who cannot join
- 1. Patients taking antibiotics in the last two weeks. 2. Symptomatic UTI. 3. Suspected urinary tract abnormalities. 4. Urinary catheterization. 5. Renal dialysis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: 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
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%)
- Conditions
- Bacteriuria in Pregnancy
- Being tested
- urine analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine analysisDiagnostic test
Intervention is (urine analysis ): of a mid stream urine sample will be taken
| Study group | Role | What they receive |
|---|---|---|
| pregnant women in first Trimester | A urine sample will be taken from pregnant women before 14 weeks of pregnancy Receives: 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 Receives: 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 Receives: Diagnostic Test: urine analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who will discovered to have bacteriuria
Incidence of asymptomatic bacteriuria among pregnant females.
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start17 Apr 2018
- Primary completion1 May 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteriuria in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499561
- Sponsor's protocol ID
- A symptomatic bacteriuria
- Status last verified
- Jan 2019
- First submitted
- 6 Apr 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research will be published after finishing results
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Symptomatic Bacteriuria in Pregnant Females
- ClinicalTrials.gov ID
- NCT03499561
- Acronym / sponsor ID
- A symptomatic bacteriuria
- Conditions
- Bacteriuria in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregnant women in first Trimester | – | Diagnostic Test: urine analysisA urine sample will be taken from pregnant women before 14 weeks of pregnancy |
| pregnant women in second Trimester | – | Diagnostic Test: urine analysisA urine sample will be taken from pregnant women from 14 weeks +1 day till 28 weeks |
| pregnant women in third Trimester | – | Diagnostic Test: urine analysisA urine sample will be taken from pregnant women from 28 weeks +1 day till 40 weeks |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant non-symptomatic females.
Key inclusion criteria (1 listed)
- 1. Pregnant females 2. Non-symptomatic females.
Key exclusion criteria (1 listed)
- 1. Patients taking antibiotics in the last two weeks. 2. Symptomatic UTI. 3. Suspected urinary tract abnormalities. 4. Urinary catheterization. 5. Renal dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine analysisIntervention is (urine analysis ): of a mid stream urine sample will be taken | Diagnostic test | pregnant women in first Trimester, pregnant women in second Trimester, pregnant women in third Trimester |
Primary outcome
The number of participants who will discovered to have bacteriuria
Time frame: within 4 weeks
Incidence of asymptomatic bacteriuria among pregnant females.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No. The research will be published after finishing results
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Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteriuria in Pregnancy, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy, M.s.c (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who will discovered to have bacteriuria (time frame: within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.