Blood Coagulation Disorders Clinical Trial
Official title:
The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
We propose a prospective cohort study to assess the effect of the progesterone only
contraceptive pill (minipill) on coagulation parameters known to be associated with risk of
thrombosis (blood clots) in women who are at increased risk for forming blood clots. We plan
to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein) and
women with a history of blood tests which demonstrate an increased risk of thrombosis who
desire contraception.
Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to
starting the minipill), one and three months. Stored samples will be used to measure
D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S,
fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio
(nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment. This
exam and the blood testing will be provided free of charge. Patients will not be prescribed
the minipill after completion of the study and will be advised to consult with their primary
care physician or hematologist if they wish to continue this medication.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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