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

Jazz Pharmaceuticals50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Maternal Complications Pregnancy Complication Birth Outcomes, Adverse Pregnancy

Interventions

EpidiolexDRUG

Oral solution

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (2)

United Biosource LLC

Morgantown, West Virginia, United States

RECRUITING

Vivantes Humboldt-Klinikum Klinik für Neurologie

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Rate of MCM

Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age

Time frame: Up to 12 months post birth

Secondary Outcomes

Rate of pregnancy outcomes

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

Time frame: 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: 1. Hospitalizations for serious illness 2. Medications 3. Growth and development milestones 4. Neonatal or infant mortality 5. Inherited epilepsy syndrome

Time frame: Up to 12 months post birth

Rate of maternal complications during pregnancy

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)

Time frame: Up to 10 months gestation

Central Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Data from ClinicalTrials.gov

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