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
Overview
- Phase
- N/A
- Intervention
- Epidiolex
- Conditions
- Maternal Complications
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of MCM
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
Arms & Interventions
Retrospective Pregnancy
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.
Intervention: Epidiolex
Prospective Pregnancy
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.
Intervention: Epidiolex
Outcomes
Primary Outcomes
Rate of MCM
Time Frame: Up to 12 months post birth
Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age
Secondary Outcomes
- Rate of pregnancy outcomes(Up to 10 months gestation)
- Rate of maternal complications during pregnancy(Up to 10 months gestation)
- Rate of other events of interest in the developing neonate and infant(Up to 12 months post birth)