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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06499779

Acronym

VALPRO

Enrollment

Registered

2024-07-12

Start date

2024-01-02

Completion date

2026-05-02

Last updated

2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Disorder

Keywords

Psychiatric disorder, Valproate

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

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.)

Design outcomes

Primary

Measure	Time frame	Description
Cause of valproate prescription in women of childbearing age	Up to 2 years	Calculation of percentages, mean, median, standard deviation The results will be considered significant at the 5% threshold.

Countries

France

Contacts

Primary ContactSébastien WEIBEL, MD

sebastien.weibel@chru-strasbourg.fr33 3 88 11 51 57

Outcome results