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

NCT06499779 | Recruiting

• 1 other identifier: 9135
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder

Keywords

Psychiatric disorder; Valproate

Outcome Measures

Primary Outcomes (1)

• Cause of valproate prescription in women of childbearing age

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

  Up to 2 years

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject female (≥16 years old) having 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,

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Psychiatrie 2 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Sébastien WEIBEL, MD

CONTACT

33 3 88 11 51 57; sebastien.weibel@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: January 2, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 2, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (1)