Blood Thinners for Pregnancy with Mechanical Heart Valves
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this pilot study is to collect data on pregnancies with mechanical heart valves to see if using a blood thinner called low molecular weight heparin (LMWH) and low dose aspirin (LDA) is comparable to warfarin/vitamin K antagonist (VKA) to reduce the chance of clotting around the mechanical valve and improve survival. The study is a pilot study as the study investigators need to ensure that the blood levels needed for adequate amounts of LMWH and warfarin can be maintained during pregnancy to be able to compare LMWH and aspirin to warfarin. If this study shows that we can collect the tests that are needed for a larger study, the individuals' information who participated in this pilot study will be moved to the larger study. The larger study will compare survival, clot development and cardiac function as well as safety of these two common blood thinners.
Are You a Good Fit for This Trial?
This trial is for pregnant women who have a mechanical heart valve and need to take blood thinners. Participants should be able to follow the study's medication and testing requirements.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares different ways of using blood thinners during pregnancy: LMWH with or without low-dose aspirin, warfarin (a vitamin K antagonist) with or without aspirin, and switching between these treatments. The goal is to find the safest option for mother and baby.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
VKA use will require INRs every two weeks or weekly (done at least 5 days after starting or changing the dose) if there is a change in doses to ensure an INR of 2.5 for and aortic MVR and 3 for a mitral MVR or two MHVs is met.
LMWH at 6 weeks gestation until 12 weeks gestation prescribed according to the regimens above then VKAs from 12 weeks gestation until 34-36 weeks gestation followed by twice daily LMWH. VKA use will require INRs every two weeks or weekly (done at least 5 days after starting or changing the dose) if there is a change in doses to ensure an INR of 2.5 for an aortic MVR (INR of 2 for the On-X AVR) and 3 for mitral MVR or two MHVs is met. LMWH will be administered twice daily according to pregnancy weight or anti-Xa level
Therapeutic LMWH throughout pregnancy either using weight-based dosing or dosing according to peak and/or trough anti-Xa levels (measured after at least 4 days of starting or change of dose) and LDA
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor
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