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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06113237

Enrollment

Registered

2023-11-02

Start date

2025-08-05

Completion date

2033-08-31

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Epidiolex, Epidyolex

Brief summary

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

DRUGEpidiolex

Oral solution

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of MCM	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

Measure	Time frame	Description
Rate of pregnancy outcomes	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
Rate of other events of interest in the developing neonate and infant	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
Rate of maternal complications during pregnancy	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)

Countries

United States

Contacts

CONTACTClinical Trial Disclosure & Transparency

ClinicalTrialDisclosure@JazzPharma.com215-832-3750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026