Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Caen University Hospital

Status: Unknown

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

Treatments: Drug: Antidepressant

Study type: Observational

Funder types: Other

Identifiers

NCT04830241

HYPOTONIA

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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