Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-01 @ 5:32 PM
Study NCT ID:
NCT00458666
Status:
UNKNOWN
Last Update Posted:
2007-04-11
First Post:
2007-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulation Parameters During Pregnancy in Amniotic Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-04-10', 'studyFirstSubmitDate': '2007-04-10', 'studyFirstSubmitQcDate': '2007-04-10', 'lastUpdatePostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amniotic fluid', 'D-dimer', 'coagulation', 'factor X activation'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.', 'detailedDescription': 'Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing amniocentesis during 15-35 weeks of gestation.\n\nExclusion Criteria:\n\n* A history of venous thromboembolism\n* Systemic disease i.e.; diabetes, hypertension, hypo or hyper-thyroidism,\n* Anticoagulant treatment\n* Abnormal embryo'}, 'identificationModule': {'nctId': 'NCT00458666', 'briefTitle': 'Coagulation Parameters During Pregnancy in Amniotic Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Coagulation Parameters During Pregnancy in Amniotic Fluid', 'orgStudyIdInfo': {'id': 'CoagulationAmnioticFluid_CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arie Drugan, M.D', 'role': 'CONTACT', 'email': 'a_drugan@rambam.health.gov.il', 'phone': '+972-50-206-2006'}], 'facility': 'Dept of Obstetrics and Gynecology, Rambam-Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Galit Sarig, Ph.D', 'role': 'CONTACT', 'email': 'g_sarig@rambam.health.gov.il', 'phone': '+972-50-2061462'}], 'overallOfficials': [{'name': 'Benjamin Brenner, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Arie Drugan, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}