Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-03 @ 2:12 PM
Study NCT ID:
NCT03499561
Status:
UNKNOWN
Last Update Posted:
2019-01-09
First Post:
2018-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Smptomatic Bacteriuria in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016482', 'term': 'Urinalysis'}], 'ancestors': [{'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants who will discovered to have bacteriuria', 'timeFrame': 'within 4 weeks', 'description': 'Incidence of asymptomatic bacteriuria among pregnant females.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacteriuria in Pregnancy']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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\n\nThe 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%)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '17 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant non-symptomatic females.', 'genderDescription': 'pregnant females with no symptoms', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Pregnant females 2. Non-symptomatic females.\n\nExclusion Criteria:\n\n* 1\\. Patients taking antibiotics in the last two weeks. 2. Symptomatic UTI. 3. Suspected urinary tract abnormalities. 4. Urinary catheterization. 5. Renal dialysis.'}, 'identificationModule': {'nctId': 'NCT03499561', 'briefTitle': 'a Smptomatic Bacteriuria in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'a Symptomatic Bacteriuria in Pregnant Females', 'orgStudyIdInfo': {'id': 'A symptomatic bacteriuria'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnant women in first Trimester', 'description': 'A urine sample will be taken from pregnant women before 14 weeks of pregnancy', 'interventionNames': ['Diagnostic Test: urine analysis']}, {'label': 'pregnant women in second Trimester', 'description': 'A urine sample will be taken from pregnant women from 14 weeks +1 day till 28 weeks', 'interventionNames': ['Diagnostic Test: urine analysis']}, {'label': 'pregnant women in third Trimester', 'description': 'A urine sample will be taken from pregnant women from 28 weeks +1 day till 40 weeks', 'interventionNames': ['Diagnostic Test: urine analysis']}], 'interventions': [{'name': 'urine analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Intervention is (urine analysis ): of a mid stream urine sample will be taken', 'armGroupLabels': ['pregnant women in first Trimester', 'pregnant women in second Trimester', 'pregnant women in third Trimester']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Alalfy, master', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '+201002611058'}, {'name': 'Ahmed Elgazzar, M.D', 'role': 'CONTACT', 'phone': '+201014005959'}, {'name': 'Mahmoud Alalfy, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mahmoud Alalfy, M.s.c', 'role': 'CONTACT', 'email': 'mahmoudalalfy@ymail.com', 'phone': '01002611058'}], 'overallOfficials': [{'name': 'Mahmoud Alalfy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The research will be published after finishing results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital', 'investigatorFullName': 'Mahmoud Alalfy', 'investigatorAffiliation': 'Aljazeera Hospital'}}}}