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

Recruiting

• Conditions: Maternal Complications; Pregnancy Complication; Birth Outcomes, Adverse; Pregnancy
• Interventions: Drug: Epidiolex

• Registration Number: NCT06113237
• Lead Sponsor: Jazz Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Study Start: 2025-07-30
• Primary Completion: 2033-08-31
• Study Completion: 2033-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Pregnancy	Epidiolex	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.
Prospective Pregnancy	Epidiolex	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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

Trial Locations

Locations (1)

United Biosource LLC; 🇺🇸 Morgantown, West Virginia, United States