Bempedoic Acid Pregnancy Surveillance Program

Major congenital malformations (MCM)

An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention (CDC 2019a). MCMs will be defined and coded with criteria specified by US CDC Metropolitan Atlanta Congenital Defects Program (MACDP).

Minor congenital malformation

An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual (CDC 2019a). The surveillance program defines and codes minor congenital malformations with criteria specified as defined by CDC (CDC 2017).

Spontaneous abortion

An involuntary fetal loss or the expulsion of the products of conception occurring at \< 20 gestational weeks.

Stillbirth

As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at ≥ 20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥ 350 g.

Elective termination

A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities.