Clinical Trial Radar

This clinical trial, identified as NCT06113237, is an important observational study focused on understanding the effects of Epidiolex/Epidyolex exposure during pregnancy.

📋 Overview

This study is designed as a Pregnancy Surveillance Program. Its main goal is to carefully track and evaluate the health outcomes of individuals who have been exposed to the medication Epidiolex/Epidyolex at any point during their pregnancy, or shortly before conception. It also monitors the health of their infants for up to 12 months after birth. The study aims to gather crucial safety information about this medication when used during pregnancy.

🔬 Terminology

• Epidiolex/Epidyolex: This is a prescription medication containing cannabidiol (CBD), approved for treating seizures associated with certain rare and severe forms of epilepsy (Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex).
• Observational Study: Unlike an interventional trial where researchers assign treatments, an observational study simply observes and collects data on participants in their natural settings. In this case, researchers are observing individuals who are already taking Epidiolex/Epidyolex during pregnancy.
• Prospective Cohort Study: This means the study identifies a group (cohort) of individuals (those exposed to Epidiolex/Epidyolex during pregnancy) and follows them forward in time to see what outcomes develop.
• LMP (Last Menstrual Period): A common reference point used in pregnancy to estimate gestational age.
• Major Congenital Malformation (MCM): Significant structural defects present at birth that can affect various body systems.

🎯 Purpose

The primary purpose of this study is to determine the rate of major congenital malformations (MCM) in infants whose mothers were exposed to Epidiolex/Epidyolex during pregnancy. Beyond MCMs, the study also aims to assess:

• Various pregnancy outcomes (e.g., miscarriage, stillbirth, preterm birth).
• Other health events and developmental milestones in the infants.
• Any complications experienced by the mother during pregnancy.

🧪 Study Design

This is a prospective, observational cohort study. This design allows researchers to follow pregnant individuals who have been exposed to Epidiolex/Epidyolex and systematically collect data on their pregnancies and their infants' health over time. The study will track participants from early pregnancy through delivery, and their infants for the first 12 months of life.

✅ Participation & Eligibility

This study is recruiting female participants who meet specific criteria:

• They must have been exposed to at least one dose of Epidiolex/Epidyolex within 13 days prior to their last menstrual period (LMP) or at any time during their pregnancy.
• They must provide informed consent to participate.
• Exclusion criteria specify that individuals exposed only to non-regulatory approved CBD products (without Epidiolex exposure) are not eligible.

The study population includes pregnant individuals who are already using Epidiolex/Epidyolex, likely for conditions like epilepsy.

📊 Outcomes Being Measured / Endpoints

The study is meticulously tracking several health outcomes:

• Primary Outcome:

  • The rate of Major Congenital Malformation (MCM) identified in the developing neonate and infant up to 12 months of age.

• Secondary Outcomes:

  • Pregnancy outcomes: This includes rates of spontaneous abortion, elective or therapeutic abortion, fetal death/stillbirth, molar or ectopic pregnancy, preterm delivery, and live birth.
  • Infant outcomes: Rates of hospitalizations for serious illness, medication use, growth and development milestones, neonatal or infant mortality, and inherited epilepsy syndromes, all followed up to 12 months post-birth.
  • Maternal complications during pregnancy: Rates of conditions like premature rupture of membranes (PROM), pre-eclampsia, severe pregnancy-induced hypertension, proteinuria, gestational diabetes, and intrauterine growth restriction (IUGR) or other measures of fetal growth deficiency.

📈 Related Research & Trends

Understanding the safety of medications during pregnancy is critically important, especially for drugs used to manage chronic conditions like epilepsy. This type of surveillance program helps build a comprehensive safety profile for Epidiolex/Epidyolex, providing valuable data that can inform healthcare providers and pregnant individuals about potential risks and benefits. Such studies contribute to pharmacovigilance efforts, ensuring that drug safety is continuously monitored in real-world settings.

💡 Why This Trial is Important

This trial is vital because it addresses a significant gap in medical knowledge regarding the safety of Epidiolex/Epidyolex during pregnancy. For individuals managing conditions that require this medication, having robust data on its effects on pregnancy and infant development is essential for making informed treatment decisions with their healthcare providers.

💬 Do you have any specific questions about the outcomes being measured, or perhaps about the medication Epidiolex/Epidyolex itself?

You can find more detailed information, including complete eligibility criteria and study contacts, on the Trial Radar Card View under the 'Participation' and 'Study Plan' tabs.

📢 Always consult with your healthcare provider for personalized medical advice and decisions regarding your health and treatment options.

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