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NCT Number: NCT06113237

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

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.

Recruiting

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Key information

Conditions

Maternal Complications Birth Outcomes, Adverse Female Urogenital Diseases and Pregnancy Complications Pregnancy Pregnancy Complication Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Vivantes Humboldt-Klinikum Klinik für Neurologie, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Epidiolex

Drug

Oral solution

Other names: Epidyolex, Cannabidiol

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of pregnancy outcomes

    Time frame: Up to 10 months gestation

    Rate of the following pregnancy outcomes:

    • Spontaneous abortion
    • Elective or therapeutic abortion
    • Fetal death/stillbirth
    • Molar or ectopic pregnancy
    • Preterm delivery
    • Live birth

  2. 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:

    • Hospitalizations for serious illness
    • Medications
    • Growth and development milestones
    • Neonatal or infant mortality
    • Inherited epilepsy syndrome

  3. Rate of maternal complications during pregnancy

    Time frame: Up to 10 months gestation

    Rate of the following maternal complications during pregnancy:

    • Premature rupture of membranes (PROM)
    • Pre-eclampsia
    • Severe pregnancy-induced hypertension
    • Proteinuria
    • Gestational diabetes
    • Intrauterine growth restriction (IUGR)
    • Measures of fetal growth deficiency (small for gestational age)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Disclosure & Transparency

CONTACT

[email protected]

215-832-3750

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Nov 2, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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