Study identification

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

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Swansea University Medical School
United Kingdom
First published:
01/02/2024
Institution Educational Institution Hospital/Clinic/Other health care facility

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:
Actual:
Sources of funding
Other

More details on funding

EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable