Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT00260520
Status:
TERMINATED
Last Update Posted:
2006-03-06
First Post:
2005-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LMWH to Prevent Preeclampsia and Fetal Growth Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'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': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017985', 'term': 'Dalteparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL'}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'completionDateStruct': {'date': '2003-12'}, 'lastUpdateSubmitDate': '2006-03-03', 'studyFirstSubmitDate': '2005-11-30', 'studyFirstSubmitQcDate': '2005-11-30', 'lastUpdatePostDateStruct': {'date': '2006-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Low molecular weight heparin', 'Preeclampsia', 'Fetal Growth Restriction', 'Thrombophilia', 'Factor V Leiden', 'G20210A prothrombin gene mutation'], 'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.', 'detailedDescription': 'The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous severe preeclampsia\n* Previous severe fetal growth restriction\n* Heterozygous Factor V Leiden\n* Heterozygous G20210A prothrombin gene mutations\n\nExclusion Criteria:\n\n* renal disease\n* chronic hypertension\n* preexisting diabetes mellitus\n* homozygosity for Factor V Leiden\n* homozygosity for prothrombin G20210A mutation\n* hyperhomocysteinemia\n* protein C deficency\n* protein S deficency\n* antithrombin deficiency\n* positive anticardiolipin antibodies\n* positive lupus anticoagulant'}, 'identificationModule': {'nctId': 'NCT00260520', 'briefTitle': 'LMWH to Prevent Preeclampsia and Fetal Growth Restriction', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation', 'orgStudyIdInfo': {'id': '06-03-1942'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dalteparin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giorgio Mello, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}}}}