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Recruiting
NCT06113237
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Conditions: Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
Sex: Female
Healthy volunteers: No
Enrollment: 50
Sponsor: Jazz Pharmaceuticals
Location: United Biosource LLC Morgantown West Virginia
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 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.
Source: ClinicalTrials.gov (NCT06113237). StuddyBuddy aggregates publicly available trial information.
