Study identification

PURI

https://redirect.ema.europa.eu/resource/48598

EU PAS number

EUPAS39438

Study ID

48598

Official title and acronym

CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Italy
Norway
Spain
Sweden
United Kingdom

Study description

A retrospective multi-database dynamic cohort study, conducted during the years 2018 to 2020, including a period of SARS-CoV-2 circulation in Europe. The study population includes women of reproductive age (12-55 years), pregnant women and their children. The study will include data from 9 electronic health care registries in 8 European countries. Descriptive analysis will focus on 3-monthly prevalence rates of medication use, incidence rates of COVID-19 outcomes and prevalence of pregnancy outcomes. The primary objectives are: 1) To estimate the prevalence of medicines used, by trimester of pregnancy, and compare this among pregnant women with COVID-19, pregnant women without COVID-19, and non-pregnant women with COVID-19. 2)To describe severity and clinical outcomes of COVID-19 disease in pregnant women with COVID-19, according to treatments received during pregnancy, and compare these data with those of nonpregnant women of reproductive age with COVID-19. 3) To assess and compare the rates of adverse maternal and neonatal outcomes in pregnant women with and without COVID-19, using different medicines.

Study status

Ongoing
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
University of Oslo Norway, Aarhus University Hospital Denmark, University of Copenhagen Denmark, FISABIO Spain, IACS Spain, Swansea University UK

Networks

Contact details

Hedvig Nordeng

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

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

ProtocolCONSIGNWP1v1.0_EUPASS

English (2.11 MB - PDF)View document
Updated protocol

EUPAS39438 CONSIGN WP1 protocol including amendment 1

English (2.31 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable