Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00215969
Status:
UNKNOWN
Last Update Posted:
2006-02-02
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study in Pregnant Women With Hypercoagulopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}, {'id': 'D019851', 'term': 'Thrombophilia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2007-10'}, 'lastUpdateSubmitDate': '2006-02-01', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2006-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Pre-eclampsia', 'Pregnancy', 'Hypercoagulation', 'Screening', 'Cardiovascular complications'], 'conditions': ['Pre-Eclampsia', 'Eclampsia']}, 'descriptionModule': {'briefSummary': 'Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.', 'detailedDescription': '600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. On a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. In addition a DNA-sample is taken if consented in order to evaluate genetic factors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women attending the midwife at Hilleroed Hospital, Frederiksborg County, Denmark.\n\nExclusion Criteria:\n\n* Mental disease.\n* Problems understanding or reading Danish.'}, 'identificationModule': {'nctId': 'NCT00215969', 'briefTitle': 'Prospective Study in Pregnant Women With Hypercoagulopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'Prospective Study of Hypercoagulation in Pregnant Women', 'orgStudyIdInfo': {'id': 'PR0104'}}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hilleroed', 'state': 'Frederiksborg County', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jørgen G Berthelsen, MD', 'role': 'CONTACT', 'email': 'jgb@dadlnet.dk', 'phone': '+45 4829 3707'}, {'name': 'Anita S Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Gynaecology and Obstetrics, Hilleroed Hospital'}, {'zip': '3400', 'city': 'Hilleroed', 'state': 'Frederiksborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jørgen G Berthelsen, MD', 'role': 'CONTACT', 'email': 'jgb@dadlnet.dk', 'phone': '4829 3707'}], 'facility': 'Department of Gynaecology and Obstetrics'}], 'centralContacts': [{'name': 'Anita S Andersen, MD', 'role': 'CONTACT', 'email': 'asan@fa.dk', 'phone': '+45 4829 6828'}], 'overallOfficials': [{'name': 'Anita S Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Clinical Trials, Denmark', 'class': 'OTHER_GOV'}, {'name': 'Loyola University', 'class': 'OTHER'}]}}}