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

May 14, 2026 updated by: Jazz Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13509
        • Recruiting
        • Vivantes Humboldt-Klinikum Klinik für Neurologie
  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26508
        • Recruiting
        • United Biosource LLC

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants who were exposed to at least one dose of Epidiolex/Epidyolex during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Pregnancy
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.
Drug: Epidiolex
Oral solution
Other Names:
  • Cannabidiol
  • Epidyolex
Prospective Pregnancy
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.
Drug: Epidiolex
Oral solution
Other Names:
  • Cannabidiol
  • Epidyolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of MCM
Time Frame: Up to 12 months post birth
Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age
Up to 12 months post birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pregnancy outcomes
Time Frame: Up to 10 months gestation

Rate of the following pregnancy outcomes:

  1. Spontaneous abortion
  2. Elective or therapeutic abortion
  3. Fetal death/stillbirth
  4. Molar or ectopic pregnancy
  5. Preterm delivery
  6. Live birth
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 the following other events of interest in the developing neonate and infant:

  1. Hospitalizations for serious illness
  2. Medications
  3. Growth and development milestones
  4. Neonatal or infant mortality
  5. Inherited epilepsy syndrome
Up to 12 months post birth
Rate of maternal complications during pregnancy
Time Frame: Up to 10 months gestation

Rate of the following maternal complications during pregnancy:

  1. Premature rupture of membranes (PROM)
  2. Pre-eclampsia
  3. Severe pregnancy-induced hypertension
  4. Proteinuria
  5. Gestational diabetes
  6. Intrauterine growth restriction (IUGR)
  7. Measures of fetal growth deficiency (small for gestational age)
Up to 10 months gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jazz Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2025

Primary Completion (Estimated)

August 31, 2033

Study Completion (Estimated)

August 31, 2033

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GWEP21095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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