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NCT04830241 Clinical Trial

Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04830241
Other study ID # HYPOTONIA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 25, 2021
Est. completion date May 1, 2021

Study information
Verified date March 2021
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10000
Est. completion date May 1, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 30 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Caen University Hospital Caen Normandy

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary neonatal hypotonia Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021
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