Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Antidepressant Drug Adverse Reaction
Drug-Related Side Effects and Adverse Reactions
Muscle Hypotonia
Neonatal Hypotonia
Neuromuscular Diseases
Pregnancy Related

Clinical Trial Details

NCT number	NCT04830241
Study type	Observational
Source	University Hospital, Caen
Contact
Status	Active, not recruiting
Phase
Start date	March 25, 2021
Completion date	May 1, 2021

View Details

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