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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidiolex | Drug | Oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of pregnancy outcomes | Rate of the following pregnancy outcomes:
| Up to 10 months gestation |
| Rate of other events of interest in the developing neonate and infant |
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Inclusion Criteria:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Contact | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Biosource LLC | Recruiting | Morgantown | West Virginia | 26508 | United States | |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Rate of the following other events of interest in the developing neonate and infant:
|
| Up to 12 months post birth |
| Rate of maternal complications during pregnancy | Rate of the following maternal complications during pregnancy:
| Up to 10 months gestation |
| Vivantes Humboldt-Klinikum Klinik für Neurologie |
| Recruiting |
| Berlin |
| 13509 |
| Germany |