Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
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|ClinicalTrials.gov Identifier: NCT00721591|
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : November 1, 2016
|Condition or disease|
|Recurrent Pregnancy Loss Fetal Demise Abortion, Habitual Antiphospholipid Antibodies Inherited Thrombophilia|
This study's specific objectives include:
- 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.
- 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.
- Documenting maternal and fetal complications during pregnancy for dalteparin and UFH, using the revised dosing protocols.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||July 2014|
Subjects opting for treatment with unfractionated heparin
Subjects opting for treatment with low molecular weight heparin
- The best dosing strategy for either unfractionated or low molecular weight heparin will be the one exhibiting the best balance between a modified Akaike information criterion value, residual sum of squares, and coefficient of determination. [ Time Frame: Pre-pregnancy, 1st, 2nd, 3d Trimester and post-partum ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721591
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Mary D. Stephenson, MD, MSc||University of Chicago|