Examining the use of valproate in women of childbearing age
Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study
This study looks at why fewer women of childbearing age with mental health issues are being prescribed valproate and what that means for their health and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06499779 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prescription patterns of valproate and its derivatives among women of childbearing age diagnosed with psychiatric disorders. It aims to understand the reasons behind the significant decrease in prescriptions and the ongoing risks associated with valproate exposure during pregnancy. The study will collect qualitative data from participants who have been prescribed valproate between January 2021 and December 2022, focusing on their experiences and the implications for maternal and child health. The findings may help inform better prescribing practices and patient education.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 16 and older who have been prescribed valproate or its derivatives for psychiatric disorders.
Not a fit: Patients who are not female or those who have not been prescribed valproate during the specified period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and health outcomes for women of childbearing age and their children regarding the use of valproate.
How similar studies have performed: While there have been studies on the risks of valproate use during pregnancy, this qualitative approach focusing specifically on women of childbearing age is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Strasbourg
- Service de Psychiatrie 2 - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sébastien WEIBEL, MD
- Email: sebastien.weibel@chru-strasbourg.fr
- Phone: 33 3 88 11 51 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.