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.
Study Type
OBSERVATIONAL
Enrollment
20
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
The Mavacamten Pregnancy Surveillance Program, PPD Inc
Wilmington, North Carolina, United States
RECRUITINGPregnancy outcomes
(1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications
Time frame: Up to 10 months
Fetal/neonatal/infant outcomes
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
Time frame: Up to 12 months post pregnancy outcome
First line of the email MUST contain NCT # and Site #.
CONTACT
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