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

Study type

• Study type:
  Not applicable

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AX24) cannabidiol

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  Pregnancy outcomes and pregnancy complications in patients who were exposed to at least 1 dose of Epidiolex during the 13 days prior to their LMP or during pregnancy The prevalence of MCM identified in fetuses, neonates, and infants, and the prevalence of other events of interest identified in neonates and infants through 12 months of age who were exposed to at least 1 dose of Epidiolex in utero
• Data analysis plan:
  Data regarding MCM will be presented as proportions (percent of total outcomes) and prevalence rates and 95% confidence interval (CI) will be presented. Data will be presented for the proportion of the total number of pregnancies that result in spontaneous abortion, elective or therapeutic abortion, fetal death/stillbirth, or preterm delivery, and for infants who are small for gestational age. The proportion of pregnancies that result in live births of infants that experience complications, such as delays in growth and development milestones, and hospitalizations during the first 12 months of life for infants at 3, 6, 9, and 12 months of age ± 2 weeks, will be calculated.