Clinical Trial: Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University of Chicago
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Chicago
Dates:
Date Received: July 22, 2008
Date Started: March 2005
Date Completion:
Last Updated: October 31, 2016
Last Verified: October 2016
