Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT02842216
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2016-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-18', 'studyFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of registered medicines and supplements in hospital medical records of Belgian pregnant women', 'timeFrame': 'Hospital medical records from 11 months before delivery until 1 month postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmaceutical preparations', 'Dietary supplements'], 'conditions': ['Medication and Supplement Use During Pregnancy']}, 'descriptionModule': {'briefSummary': 'Monocentric study in University Hospitals Leuven (campus Gasthuisberg).\n\nHospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements.\n\nSome demographic and obstetric parameters will be collected as well.\n\nThe anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who delivered in the University Hospital of Leuven', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015'}, 'identificationModule': {'nctId': 'NCT02842216', 'briefTitle': 'Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women', 'orgStudyIdInfo': {'id': 'MC201601'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Researcher', 'investigatorFullName': 'Michael Ceulemans', 'investigatorAffiliation': 'KU Leuven'}}}}