Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study (VALPRO)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Psychiatric Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT06499779

9135

Details and patient eligibility

About

The prescription of valproate in women of childbearing age has decreased by 82% in France, for mood disorders. Exposure to valproate during pregnancy 60%. However, the ANSM sent an alert document in August 2022 because there are still patients on valproate. In addition, there were 32 births taking valproate to mothers with bipolar disorder in 2018. The risks of exposure during pregnancy which occur in 10% of exposure cases are: congenital malformations; neurodevelopmental disorders including autism spectrum disorders, attention deficit disorders more or less hyperactivity, language disorders, motor disorders, mental delays; reduction in social, attentional, motor and language abilities; a lower level of education.

Enrollment: 50 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject (≥16 years old)
• Female gender
• Prescription of Valproate and/or derivatives (Sodium Divalproate, Valpromide, Valproic Acid, Sodium Valproate) in an indication of psychiatric disorder for the period from January 1, 2021 to December 31, 2022,
• Subject not opposing, after information, the reuse of their data for the purposes of this research
• Holders of parental authority who do not object, after information, to the reuse of their child's data for the purposes of this research

Exclusion criteria

• Subject and/or holder of parental authority having expressed opposition to participating in the study
• Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)