Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499779
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Prescription of Valproate and Derivatives in Women of Childbearing Age Qualitative Study
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Prescription of Valproate and Derivatives in Women of Childbearing Age Qualitative Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALPRO
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None