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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-02

Study Completion Date

2026-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Psychiatric Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.)

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No