Study detail
Recruiting
Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
Jazz Pharmaceuticals
Summary
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: 1. Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 days prior to their LMP or at any time during pregnancy. 2. Verbal or written informed consent to participate Exclusion criteria: 1\) Patients exposed to a non-regulatory approved product containing Cannabidiol (CBD) during pregnancy who do not also have exposure to Epidiolex during the 13 days prior to their LMP or during the pregnancy.
Interventions
- DrugEpidiolex
Oral solution
Location
- United Biosource LLCMorgantown, West Virginia