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Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy

NCT06113237

RecruitingN/A

Sponsor: Jazz Pharmaceuticals

Conditions: Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy

Interventions: Epidiolex

Countries: United States, Germany

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 overview

Sex: FEMALE

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (2)
  • Morgantown, West Virginia, United States
  • Berlin, Germany