Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 10:34 AM
Study NCT ID:
NCT05810935
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Antibiotic Intake During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with antibiotic-related side effects', 'timeFrame': 'through study completion ,an average of one year', 'description': 'using a questionnaire to measure the knowledge and attitude of pregnant women toward antibiotics that were taken during pregnancy and any malpractice during its intake'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotics, infection'], 'conditions': ['Infections']}, 'descriptionModule': {'briefSummary': 'this study will be conducted to assess the knowledge of the pregnant females regarding safety of antibiotic intake ,also their attitude toward any prescribed antibiotics during their pregnancy .', 'detailedDescription': 'this study will be conducted on pregnant females from two Arab countries to assess their knowledge and attitude toward any prescribed antibiotics while they are pregnant .Also to assess any malpractice while their intake for any antibiotics . this study is a cross sectional study that will involve a questionnaire including the three mentioned domains .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'this study is an observational cross sectional study that will be conducted on pregnant female above the age of 18 years old iwith exclusion of any female with any psychological disability.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women at any gestational age\n\nExclusion Criteria:\n\n* pregnant women who refused to participate'}, 'identificationModule': {'nctId': 'NCT05810935', 'acronym': 'antibiotic', 'briefTitle': 'Safety of Antibiotic Intake During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Safety of Antibiotic Intake During Pregnancy: Results of Questionnaire of Pregnant Women in Two Arab Countries', 'orgStudyIdInfo': {'id': 'DFM-IRB 00012367-23-03-004'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eman Ibrahim Abd Elrehim, Lecturer', 'role': 'CONTACT', 'email': 'ahmedea2003@gmail.com', 'phone': '02 01110985494', 'phoneExt': 'egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Department of obstetrics and gynecology, Damietta Faculty of Medicine, Al-Azhar University', 'investigatorFullName': 'Eman Ibrahim Abd Elrehim', 'investigatorAffiliation': 'Al-Azhar University'}}}}