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Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy - NCT00721591-60637(Clinical Trial 233131)



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City:  Chicago
State:  
IL
Zip Code: 60637
Conditions: Recurrent Pregnancy Loss, - Fetal Demise - Abortion, Habitual - Antiphospholipid Antibodies - Inherited Thrombophilia
Purpose: To determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited thrombophilia.
Study summary: This study's specific objectives include: 1. Evaluating pharmacokinetic (concentration-time) and pharmacodynamic (concentration- effect) parameters for dalteparin and UFH prior to pregnancy, during the 1st, 2nd and 3rd trimesters and postpartum, using revised dosing protocols based on previous study. 2. Determining therapeutic response to the heparins, i.e. live birth rate and lack of maternal or fetal complications, in relation to drug exposure, based on AUC. 3. Documenting maternal and fetal complications during pregnancy for dalteparin and UFH, using the revised dosing protocols.
Criteria: Inclusion Criteria: - Two or more consecutive, otherwise unexplained miscarriages under 10 weeks of gestation, or, an otherwise unexplained intrauterine fetal demise of at least 10 weeks of gestation, and, - Persistently positive antiphospholipid antibodies, or, presence of Factor V Leiden, or, Prothrombin 20210A, or, antithrombin, protein S, or protein C deficiency, or, hyperhomocysteinemia associated with the methylenetetrahydrofolate reductase (MTHFR) polymorphism. Exclusion Criteria: - Inability or refusal to give written informed consent. - Inability or refusal to self-administer heparin throughout pregnancy. - Hemoglobin value below 9.5 g/dL - Heparin use is contraindicated. - Renal disease. - Documented history of thrombosis.
Study is available at: The University of Chicago
Chicago, IL 60637
United States

Primary Contact:
Mary D. Stephenson, MD, MSc
Phone: 773 834-1167
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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