OBSERVATIONALRECRUITINGNCT06113237

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-20

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: Not reported
Enrollment: 50 (ESTIMATED)
Start date: 2025-08-05
Sponsor: Jazz Pharmaceuticals
Design: Not reported
Locations: 2
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol

Medicines

EPIDIOLEX Epidiolex Epidyolex Epidyolex

Interventions

What was registered

DRUG

Epidiolex

Oral solution

Epidyolex · Cannabidiol

Eligibility

Population and criteria

Sex: FEMALE
Minimum age: Not reported
Maximum age: Not reported
Healthy volunteers: Not accepted

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.

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.

primary outcomes

primary measures

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

secondary measures

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

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

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)

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 3ccb9a55-59c8-4c18-aefb-6bfe984419d9
Retrieved: 11/09/2026, 14:16:28
SHA-256: 50c014727692e8c95426388abbc8808ddbf6146da35bb9cbb61d35c09a736b6e