Trials / Recruiting
RecruitingNCT06499779
Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- University Hospital, Strasbourg, France · Academic / Other
- Sex
- Female
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2024-01-02
- Primary completion
- 2026-05-01
- Completion
- 2026-05-02
- First posted
- 2024-07-12
- Last updated
- 2024-07-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06499779. Inclusion in this directory is not an endorsement.