Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01176305
Status:
COMPLETED
Last Update Posted:
2010-08-06
First Post:
2010-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2010-08-05', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute incidence of thromboembolic event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thromboembolic event'], 'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the incidence of thromboembolic events in relation to pregnancy and when in pregnancy and the puerperal period.', 'detailedDescription': 'Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of this study is to estimate the relative and absolute risk of VTE at different gestational ages in pregnant women compared to non-pregnant women.\n\nAll Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives are included.Non-pregnant women are controls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of previous VTE and current use of oral contraceptives.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish woman at 15 to 49 years old in the period January 1995 through December 2005.\n* Free of previous VTE and current use of oral contraceptives.\n\nExclusion Criteria:\n\n* Previous VTE or current use of oral contraceptives.'}, 'identificationModule': {'nctId': 'NCT01176305', 'briefTitle': 'Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005', 'orgStudyIdInfo': {'id': 'RAV1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Danish Women 15 to 49 years old.', 'description': 'Free of previous VTE and current use of oral contraceptives.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thomas Bergholt', 'oldOrganization': 'Hillerod Hospital, Gynecolocical-Obstetrical department'}}}}