Maternal ComplicationsNCT06113237
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
An observational study of Maternal Complications and Pregnancy Complication, run by Jazz Pharmaceuticals at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse
- What is being tested?
- Epidiolex
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Aug 2025to 31 Aug 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
United Biosource LLC
Morgantown, West Virginia, 26508
Germany1 site, 1 recruiting
- Recruiting
Vivantes Humboldt-Klinikum Klinik für Neurologie
Berlin, 13509
Italy1 site, 1 recruiting
- Recruiting
JZP047-102 Research Summary for UK IRAS application
Bologna, 40138
About this study
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
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.
- Being tested
- Epidiolex
- Keywords
- Epidiolex, Epidyolex
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidiolexDrug
Also called Epidyolex, Cannabidiol
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Pregnancy | Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment. Receives: Drug: Epidiolex | |
| Prospective Pregnancy | Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment. Receives: Drug: Epidiolex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MCM
Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age
Measured: Up to 12 months post birth
Secondary outcomes (3)
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
Measured: 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:
- Hospitalizations for serious illness
- Medications
- Growth and development milestones
- Neonatal or infant mortality
- Inherited epilepsy syndrome
Measured: Up to 12 months post birth
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)
Measured: Up to 10 months gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start5 Aug 2025
- Primary completion31 Aug 2033 (estimated)
- Study completion31 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal ComplicationsStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113237
- Sponsor's protocol ID
- GWEP21095
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Individual data sharing
- No