Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epidiolex.
- Who it may be relevant to
- Registry conditions: Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug Epidiolex
Oral solution
Primary outcome measures
- Rate of MCM [Time frame: Up to 12 months post birth]
Secondary outcome measures (3)
- Rate of pregnancy outcomes [Time frame: Up to 10 months gestation]
- Rate of other events of interest in the developing neonate and infant [Time frame: Up to 12 months post birth]
- Rate of maternal complications during pregnancy [Time frame: Up to 10 months gestation]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- United Biosource LLC — Morgantown
Germany · 1 center
- Vivantes Humboldt-Klinikum Klinik für Neurologie — Berlin
Identifiers
NCT: NCT06113237 · GWEP21095