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New treatment option for Pregnancy
Official title Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves
ClinicalTrials.gov ID: NCT07658989
What this study is testing
What is LMWH and LDA?
LMWH and LDA is an investigational medicine, given as an once-weekly, being studied as a potential treatment for pregnancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Pregnant individuals with one or more MHVs
- Who consent to participate
- Are 18 years or older and
- Less than 12 weeks gestation
You likely can't join if
- Have a platelet count less than 50 x 10(9)/L as there is an increased risk of bleeding with thrombocytopenia, and/or
- Have active bleeding defined as bleeding resulting in a hemoglobin reduction ≥10 g/L or in hemodynamic instability.
- Have new valve thrombosis identified immediately prior to pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.