Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49130
• EU PAS number:
  EUPAS40317
• Study ID:
  49130
• Official title and acronym:
  Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Canada

  Denmark

  Finland

  Germany

  Iceland

  Italy

  Netherlands

  Norway

  Saudi Arabia

  Spain

  Sweden

  Switzerland

  United Kingdom

  United States
• Study description:
  This document describes ongoing initiatives and opportunities for international collaboration in the area of medicines use and their effects on management of COVID-19 in pregnancy. We will call this CONSIGN-International. The current entry in the EUPAS register includes a general description of international collaboration and a protocol and statistical analysis plan of a meta-analysis of the existing data collections.
• Study status:
  Planned

Research institution and networks

Institutions

University Medical Center Utrecht (UMCU)

Netherlands

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Fundació Institut Català de Farmacologia (FICF)

Spain

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

University Medical Center Utrecht (UMCU)

Netherlands

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Bordeaux PharmacoEpi, University of Bordeaux

France

Instituto Aragonés de Ciencias de la Salud (IACS)

Spain

Swansea University Medical School

United Kingdom

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Karolinska Institutet

Sweden

University of Manchester

United Kingdom

University of Oslo

University of Copenhagen Denmark, University of Oxford UK, FISABIO Spain, Karolinska Institutet Sweden, University of Oslo Norway, Instituto Aragonés de Ciencias de la Salud (IACS) Spain, Swansea University UK, University of Bern Switzerland, University of Manchester UK, - George Washington University - SFDA - SET-NET (CDC) - Health Canada - CAMCCO - FDA - Sentinel - University of Lausanne (CHUV) International collaborators

Networks

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Study timelines

Date when funding contract was signed

Planned: 17/07/2020

Actual: 17/07/2020

Study start date

Planned: 01/01/2021

Data analysis start date

Planned: 01/09/2022

Date of interim report, if expected

Planned: 31/03/2023

Date of final study report

Planned: 28/07/2023

Sources of funding

Other

More details on funding

EMA

Study protocol

Initial protocol

Deliverable 2b by the EU PE&PV research network for the CONSIGN project version1.1_20210312

Regulatory

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

Other study registration identification numbers and links

This is an EMA-tendered study