Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

• Conditions: Neonatal Hypotonia; Pregnancy Related; Antidepressant Drug Adverse Reaction

• Registration Number: NCT04830241
• Lead Sponsor: University Hospital, Caen

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

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-25
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Study First Posted: 2021-04-05
• Last Update Posted: 2021-04-05
• Primary Completion: 2021-04-15
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs

Exclusion Criteria

• Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neonatal hypotonia	Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021	Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, Normandy, France