Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
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.
Recurrent Pregnancy Loss,
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy|
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma from subjects to obtain concentrations of heparin will be retained
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Subjects opting for treatment with unfractionated heparin
Subjects opting for treatment with low molecular weight heparin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721591
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Mary D. Stephenson, MD, MSc||University of Chicago|