Bempedoic Acid Pregnancy Surveillance Program
This study is observing women who have taken bempedoic acid or a combination of bempedoic acid and ezetimibe during pregnancy. It aims to understand if these medications affect the baby's development. You can join if you are a woman aged 18 or older who has been exposed to at least one dose of bempedoic acid or bempedoic acid/ezetimibe at any point during your pregnancy, from your last menstrual period until the pregnancy outcome. The main goal is to track major birth defects in babies from birth up to 12 months of age. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 20 participants.
- What's involved
- Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.
- Compensation
- Not stated in the trial record.
- Follow-up
- Babies will be followed from birth up to 12 months to check for major congenital malformations.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Bempedoic Acid Pregnancy Surveillance Program
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christine Broestl, MS · STUDY_DIRECTOR · Esperion Therapuetics
Who to contact
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What this trial measures
- 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).