Safety of psychotropic medication in pregnancy: A pharmacovigilance study of international safety data in the World Health Organization global individual case safety report (ICSR) database ‘VigiBase’.

Study identification

• EU PAS number:
  EUPAS49262
• Study ID:
  49263
• Official title and acronym:
  Safety of psychotropic medication in pregnancy: A pharmacovigilance study of international safety data in the World Health Organization global individual case safety report (ICSR) database ‘VigiBase’.
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  The present protocol aims to use disproportionality analysis to identify safety signals of individual psychotropic drug use and pregnancy related adverse events using VigiBase, the World Health Organization global individual case safety report (ICSR) database.
• Study status:
  Planned

Research institutions and networks

Institutions

CLINICAL RESEARCH UNIT, SCHOOL OF MEDICINE, PAPAGEORGIOU GENERAL HOSPITAL, ARISTOTLE UNIVERSITY OF THESSALONIKI (CRU-AUSoM)

Greece

Department of Clinical Pharmacology & Clinical Research Unit

Study timelines

Date when funding contract was signed

Planned:25/05/2021

Study start date

Planned:10/10/2022

Data analysis start date

Planned:02/01/2023

Date of final study report

Planned:31/12/2023

Sources of funding

Other

More details on funding

Study not funded

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable