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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Maternal Complications
Intervention / Treatment

-

Contacts and Locations

Morgantown

United Biosource LLC, Morgantown, West Virginia, United States, 26508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jazz Pharmaceuticals,

Study Record Dates

2033-08-31