RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-12-01
Study Completion:2033-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06113237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Verbal or written informed consent to participate
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trial Disclosure & Transparency
CONTACT
215-832-3750
ClinicalTrialDisclosure@JazzPharma.com

Study Locations (Sites)

United Biosource LLC
Morgantown, West Virginia, 26508
United States

Collaborators and Investigators

Sponsor: Jazz Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2033-08-31

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2033-08-31

Terms related to this study

Keywords Provided by Researchers

  • Epidiolex
  • Epidyolex

Additional Relevant MeSH Terms

  • Maternal Complications
  • Pregnancy Complication
  • Birth Outcomes, Adverse
  • Pregnancy