Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830241
Status:
UNKNOWN
Last Update Posted:
2021-04-05
First Post:
2021-03-31
Brief Title:
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants so far limited to clinical cases we will perform an observational retrospective pharmacovigilance study using two databases First disproportionality analysis in Vigibase the World Health Organization global database will be perform between antidepressant drugs and neonatal hypotonia Second narratives from the French National Pharmacovigilance Database will be extracted
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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