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Sponsors and Collaborators: |
Mount Sinai Hospital, Canada CIHR Pfizer |
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Information provided by: | Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT00564174 |
To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.
Condition | Intervention |
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Recurrent Pregnancy Loss Antiphospholipid Antibody Syndrome |
Drug: Low molecular weight heparin and low dose aspirin Drug: Low dose aspirin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss |
Enrollment: | 88 |
Study Start Date: | March 2000 |
Study Completion Date: | September 2005 |
Arms | Assigned Interventions |
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a: Experimental |
Drug: Low molecular weight heparin and low dose aspirin
Fragmin 5000 IU/day by subcutaneous injection started at time of randomization and continued until 35 weeks gestation or delivery and low dose aspirin 81 mg/day started pre-conception and continued until 35 weeks gestation or delivery
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b: Active Comparator
Low dose aspirin only
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Drug: Low dose aspirin
81 mg enteric coated started pre-pregnancy and discontinued at 35 weeks or delivery
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Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.
Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Mount Sinai Hosptial | |
Toronto, Ontario, Canada, M5G 1X5 | |
McMaster Medical Centre | |
Hamilton, Ontario, Canada |
Principal Investigator: | Carl A Laskin, MD | Associate Professor, Department of Medicine, University of Toronto |
Study ID Numbers: | 33762, CIHR 37749 |
Study First Received: | November 26, 2007 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00564174 |
Health Authority: | Canada: Canadian Institutes of Health Research |
recurrent pregnancy loss lupus anticoagulant anti cardiolipin antibodies thrombophilia |
low molecular weight heparin aspirin randomized clinical trial |
Autoimmune Diseases Antiphospholipid syndrome Thrombophilia Heparin, Low-Molecular-Weight Recurrence Calcium heparin Body Weight |
Calcium, Dietary Antibodies Aspirin Dalteparin Antiphospholipid Syndrome Heparin Immunoglobulins |
Anti-Inflammatory Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Pathologic Processes Sensory System Agents Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Disease Anticoagulants Immune System Diseases Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |