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

Launched by JAZZ PHARMACEUTICALS · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how exposure to a medication called Epidiolex (or Epidyolex) during pregnancy affects the health of both mothers and their babies in the first year of life. The goal is to gather information about any pregnancy-related health issues or complications that may arise for women who have taken this medication while pregnant.

To participate in this study, women need to have taken at least one dose of Epidiolex or Epidyolex either in the 13 days before their last menstrual period (the time when they would have conceived) or at any point during their pregnancy. Participants will need to give their consent to join the study. It’s important to note that women who have taken other CBD products that are not approved for use during pregnancy will not be eligible unless they also used Epidiolex. If you qualify and choose to participate, you will help researchers understand the effects of this medication, which could improve care for future mothers and babies.

Gender

FEMALE

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.