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

ConditionsMaternal Complications Pregnancy Complication Birth Outcomes, Adverse Pregnancy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorJazz Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Epidiolex
Drug
Oral solution

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Retrospective Pregnancy1 intervention

Group B: Prospective Pregnancy1 intervention

Trial 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