NCT04830241

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

21 days

First QC Date

March 31, 2021

Last Update Submit

March 31, 2021

Conditions

Neonatal HypotoniaAntidepressant Drug Adverse ReactionPregnancy Related

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

AntidepressantDRUG

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

Also known as: in utero exposure to antidepressant drugs

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, Normandy, 14000, France

Location

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

March 25, 2021

Primary Completion

April 15, 2021

Study Completion

May 1, 2021

Last Updated

April 5, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)