Clinical Trial

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

Study acronym: VALPRO
Unknown
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Record status
This record was last updated July 12, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06499779
Lead Sponsor University Hospital, Strasbourg, France
Conditions Psychiatric Disorder
Enrollment 50 participants
Start Date 2024-01-02
Primary Completion 2026-05 (estimated)
Study Completion 2026-05-02 (estimated)
Updated on ClinicalTrials.gov 2024-07-12