Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
Conditions
Brief summary
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
Interventions
DRUGMavacamten
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy outcomes | Up to 10 months | (1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications |
| Fetal/neonatal/infant outcomes | Up to 12 months post pregnancy outcome | Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency |
Countries
United States
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed