Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Completed

Conditions studied: Recurrent Pregnancy Loss, Fetal Demise, Abortion, Habitual, Antiphospholipid Antibodies, Inherited Thrombophilia

In brief

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.

Key facts

Study ID

NCT00721591

Run by

University of Chicago

People needed

14

Starts

2005-03-01

Expected to finish

2014-07-01

Last updated by the study team

2016-11-01

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.