Recurrent Pregnancy Loss Clinical Trial
Official title:
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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