Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-23 @ 11:27 PM
Study NCT ID:
NCT00573118
Status:
UNKNOWN
Last Update Posted:
2007-12-13
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D000037', 'term': 'Abruptio Placentae'}, {'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-12', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalenc of elevated factor VIII', 'timeFrame': 'RETROSPECTIVE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5).'], 'conditions': ['Pregnancy Complications', 'Preeclampsia', 'Placental Abruption', 'Intrauterine Fetal Growth Restriction', 'Intrauterine Fetal Death']}, 'descriptionModule': {'briefSummary': 'Congenital and acquired thrombophilia were identified as risk factors for thrombosis in systemic vessels.Thrombophilias have also been recently found to be associated with preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are thought to result from thrombotic events occurring in the uteroplacental circulation. Accumulating data have established an association between elevated plasma activity of factor VIII and thrombosis although the mechanism is still not defined and elevated factor VIII activity is now regarded as being equivalent to thrombophilia.\n\nWe intend to investigatthe association between factor VIII levels and severe pregnancy complications which are considered to result from placental vascular pathology, i.e., preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of elevated factor 8 will be higher among women with pregnancy complications compared to controls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women who had either normal pregnancy or complicated pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who had either normal pregnancy or complicated pregnancy.\n\nExclusion Criteria:\n\n* Other causes of pregnancy complication such as infections, anomalies and fetal malformations'}, 'identificationModule': {'nctId': 'NCT00573118', 'briefTitle': 'Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'A Retrospective Analysis of Possible Association Between Severe Pregnancy Complications and Elevated Factor VIII Plasma Activity.', 'orgStudyIdInfo': {'id': 'FactorVIII'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The study group included 49 patients with a previous history of one or more of the following pregnancy complications: preeclampsia (n = 17), severe IUGR (n = 13), IUFD (n = 14) or placental abruption (n = 5).'}, {'label': '2', 'description': 'The control group included 49 healthy women who delivered during the study period, who did not smoke during pregnancy and in whom pregnancy and delivery were uneventful'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Avis sourasky medical center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Eli Rimon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv medical center,Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Eli Rimon,MD', 'oldOrganization': 'Tel Aviv medical center; Israel'}}}}