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

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
InstitutionNot-for-profitENCePP partner
Swansea University Medical School
United Kingdom
First published:
01/02/2024
InstitutionEducational InstitutionHospital/Clinic/Other health care facility
Karolinska Institutet
Sweden
First published:
01/02/2024
InstitutionEducational Institution
University of Manchester
United Kingdom
First published:
01/02/2024
InstitutionEducational Institution
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

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
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

English (1.28 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable