Tracks pregnancy and infant outcomes after mavacamten exposure in pregnant or breastfeeding people
Observes pregnancy and infant outcomes in people taking mavacamten during pregnancy or breastfeeding.
Plain-language title generated from the registry record
Registry title: Mavacamten Pregnancy Surveillance Program
Key facts
- Where
- Wilmington, United StatesSee the site
Where in United States
- The Mavacamten Pregnancy Surveillance Program, PPD IncWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05939700
- Record updated
- 6 November 2025
- Original description
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.Read full original descriptionShow less
Mavacamten Pregnancy Surveillance Program
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.
Inclusion: 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: None.