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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Epidiolex


Participation Criteria
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Eligibility Criteria
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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: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Pregnancy<br>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<br>* Oral solution<br>* Other names: Cannabidiol;|
| Prospective Pregnancy<br>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<br>* Oral solution<br>* Other names: Cannabidiol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MCM | 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 | Rate of the following pregnancy outcomes: Spontaneous abortion Elective or therapeutic abortion Fetal death/stillbirth Molar or ectopic pregnancy Preterm delivery Live birth | Up to 10 months gestation | 
| Rate of other events of interest in the developing neonate and infant | 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 | Up to 12 months post birth | 
| Rate of maternal complications during pregnancy | 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) | Up to 10 months gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidiolex, Epidyolex