NCT04830241

Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Hypotonia
• Antidepressant Drug Adverse Reaction
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Antidepressant	Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of neonatal hypotonia newborns following in utero exposure to antidepressant drugs, with a chronology compatible with the drug toxicity

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-04-15
• Completion: 2021-05-01
• First posted: 2021-04-05
• Last updated: 2021-04-05

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study