Pregnancy Clinical Trial
Official title:
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
NCT number | NCT06113237 |
Other study ID # | GWEP21095 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2024 |
Est. completion date | August 31, 2033 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 31, 2033 |
Est. primary completion date | August 31, 2033 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | United Biosource LLC | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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