Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Neonatal Hypotonia; Antidepressant Drug Adverse Reaction
• Intervention / Treatment: Drug: Antidepressant

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs retrived in the two pharmacovigilance database

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Anticipated): April 15, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Drug-Related Side Effects and Adverse Reactions; Neuromuscular Diseases; Muscle Hypotonia; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: HYPOTONIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No