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NCT Number: NCT06499779

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

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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Key information

Conditions

Psychiatric Disorder Mental Disorders

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de Psychiatrie 2 - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Guillaume MEYER, PharmD

PRINCIPAL_INVESTIGATOR

Léa MIREMONT, MD

PRINCIPAL_INVESTIGATOR

Sébastien WEIBEL, MD

CONTACT

[email protected]

33 3 88 11 51 57

Sébastien WEIBEL, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

Cause of valproate prescription in women of childbearing age

Time frame: Up to 2 years

Calculation of percentages, mean, median, standard deviation The results will be considered significant at the 5% threshold.

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien WEIBEL, MD

CONTACT

[email protected]

33 3 88 11 51 57

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: VALPRO

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 12, 2024
Registry last updated: Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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