Status:
COMPLETED
Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
University of British Columbia
Conditions:
Recurrent Pregnancy Loss
Fetal Demise
Eligibility:
FEMALE
18-44 years
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...
Detailed Description
This study's specific objectives include: 1. Evaluating pharmacokinetic (concentration-time) and pharmacodynamic (concentration- effect) parameters for dalteparin and UFH prior to pregnancy, during t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00721591
Start Date
March 1 2005
End Date
July 1 2014
Last Update
November 1 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Chicago
Chicago, Illinois, United States, 60637