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

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

Who can join

All ages · Women

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.

About the study

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.

What is being tested

• Epidiolex (drug)

Sponsor: Jazz Pharmaceuticals · Participants: 50 · Started: Aug 5, 2025

Contact the study team

• Clinical Trial Disclosure & Transparency · Phone: 215-832-3750

Official record on ClinicalTrials.gov — NCT06113237

Locations in the U.S.

Conditions

• Tumors and Pregnancy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.