Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves (NCT07658989)
A Prospective Multicenter Cohort Pilot Study Comparing Antithrombotic Regimens in Pregnancies With Mechanical Heart Valves
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mount Sinai Hospital — Toronto, Ontario
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Mount Sinai Hospital — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 586-5133
Email: nadine.shehata@sinaihealth.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Pregnancy
- Mother and Infant Home Visiting Program Evaluation — New York, New York
- Maternal Stress and Blood Sugar Metabolization — Sioux Falls, South Dakota
- Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation — Chicago, Illinois
- A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery — Chicago, Illinois
- Effects of Increased Maternal Choline Intake on Child Cognitive Development — Ithaca, New York
- Michigan Contraceptive Access, Research, and Evaluation Study: Phase 1 — Ann Arbor, Michigan
Explore by condition: All Pregnancy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.