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Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

NCT04830241 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2021-04-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2021-04-15
Completion
2021-05-01
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04830241 on ClinicalTrials.gov