Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter pilot study compares two antithrombotic strategies for pregnant people with mechanical heart valves. It aims to determine whether LMWH with low-dose aspirin can achieve similar maternal and fetal safety and outcomes as warfarin-based therapy, with careful monitoring to ensure appropriate anticoagulation levels. The trial will enroll about 100 pregnancies, collect data, and use findings to plan a larger, definitive study on survival, clotting events, and cardiac function. Participation is limited to early pregnancy (<12 weeks) at qualified centers with appropriate monitoring capabilities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pregnant individuals with one or more MHVs
2. Who consent to participate
3. Are 18 years or older and
4. Less than 12 weeks gestation

Exclusion Criteria:

1. Have a platelet count less than 50 x 10(9)/L as there is an increased risk of bleeding with thrombocytopenia, and/or
2. Have active bleeding defined as bleeding resulting in a hemoglobin reduction ≥10 g/L or in hemodynamic instability.
3. Have new valve thrombosis identified immediately prior to pregnancy

Where it's running

• Mount Sinai Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Nadine Shehata, MD
• Email: nadine.shehata@sinaihealth.ca
• Phone: 4165865133

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.