Hyperlipidemias, Pregnancy
Conditions
Keywords
bempedoic acid
Brief summary
Bempedoic acid pregnancy surveillance program
Detailed description
A surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (FCDP) during pregnancy. Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.
Interventions
DRUGBempedoic Acid
Bempedoic Acid 180 MG
DRUGBempedoic Acid / Ezetimibe
Bempedoic Acid 180 MG / Ezetimibe 10 MG
Sponsors
Esperion Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
Exposure to at least 1 dose of bempedoic acid or bempedoic acid/ezetimibe FCDP at any time during pregnancy (from first day of last menstrual period \[LMP\] to pregnancy outcome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major congenital malformations (MCM) | Birth up to 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous abortion | Time of conception up to birth | An involuntary fetal loss or the expulsion of the products of conception occurring at \< 20 gestational weeks. |
| Stillbirth | Time of conception up to birth | 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 | Time of conception up to birth | A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities. |
| Minor congenital malformation | Birth up to 12 months | 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). |
| Small for gestational age (SGA) | Birth up to 12 months | Weight at birth in \< 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants (Battaglia 1967). For the determination of SGA, the surveillance program will utilize the sex-specific international growth reference standards from the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) for those born between 240/7 and 426/7 gestational weeks (Villar 2014; Villar 2016). The INTERGROWTH-21st standards are the latest available global reference standards, representing contemporary information from an international, multiethnic, diverse population, and have been specifically developed for modern research. |
| Postnatal growth deficiency | Birth up to 12 months | Weight in \< 10th percentile for sex and chronological age using standard growth charts. Postnatal growth deficiency will be evaluated at 4 and 12 months of infant age. For the determination of postnatal growth deficiency, the surveillance program will utilize the sex-specific international growth reference standards from the World Health Organization for children ages 0 to 24 months. The World Health Organization growth standards are recommended for use in the US for infants and children 0 to 2 years of age (CDC 2010). |
| Infant development deficiency | Birth up to 12 months | Failure to achieve the developmental milestones for chronological age, as defined by the CDC (CDC 2019b). Infant developmental deficiency will be evaluated at 4 and 12 months of infant age for each CDC-defined category (social/emotional, language/communication, cognitive, and movement/physical development), separately. |
| Preterm birth | Time of conception up to birth | A live birth occurring at \< 37 gestational weeks. |
Countries
United States
Contacts
Primary ContactEsperion Therapuetics
Outcome results
None listed