Mavacamten Pregnancy Surveillance Program

Launched by BRISTOL-MYERS SQUIBB · Jul 3, 2023

Keywords

ClinConnect Summary

The Mavacamten Pregnancy Surveillance Program is a study designed to understand how the medication mavacamten affects women and their babies during pregnancy and breastfeeding. Researchers want to learn about the health outcomes for mothers and their infants when mavacamten has been taken at any point from four months before pregnancy, throughout pregnancy, and while breastfeeding. This study is currently looking for women who are at least 15 years old and have taken at least one dose of mavacamten during these times.

If you participate in this study, you will share information about your health and your baby's health after being exposed to the medication. There are no specific exclusions for this trial, so if you meet the age and exposure criteria, you may be eligible. Your involvement will help provide valuable information about the safety of mavacamten during pregnancy and breastfeeding, which is important for other women and their healthcare providers.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first)
• • At least 15 years of age or older at the time of enrollment
• • Informed consent or institutional review board/ethics committee-approved waiver of informed consent
• Exclusion Criteria:
• • - None