Status: Planned First registered on: 10/02/2021
Last updated on: 10/02/2021
1. Study identification
EU PAS Register NumberEUPAS39438
Official titleCONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
Study title acronymCONSIGN
Study typeObservational study
Brief description of the studyA 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameUniversity of Oslo
Centre locationOslo, Norway
Details of (Primary) lead investigator
Title Professor
Last name Nordeng
First name Hedvig
Is this study being carried out with the collaboration of a research network?
Yes
EU PE&PV research network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?14

ARS
University of Oslo, Norway
Aarhus University Hospital, Denmark
University of Copenhagen, Denmark
Karolinska Institutet, Sweden
FISABIO, Spain
IACS, Spain
Swansea University, UK
Countries in which this study is being conducted
International study

Denmark
France
Germany
Italy
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/07/202017/07/2020
Start date of data collection01/01/2021
Start date of data analysis
Date of interim report, if expected16/07/2021
Date of final study report16/07/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Nordeng
First name Hedvig
Address line 1Department of Pharmacy
Address line 2Postboks 1068 
Address line 3Blindern 
CityOslo 
Postcode0316 
CountryNorway
Phone number (incl. country code)4722856604 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Professor 
Last name Nordeng 
First name Hedvig 
Address line 1Department of Pharmacy 
Address line 2Postboks 1068 
Address line 3Blindern 
CityOslo 
Postcode0316 
CountryNorway 
Phone number (incl. country code)4722856604 
Alternative phone number 
Fax number (incl. country code) 
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