Status: Ongoing
First registered on:
10/02/2021
Last updated on:
16/08/2022
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
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 collection01/01/202101/01/2021
Start date of data analysis
Date of interim report, if expected14/10/2021
Date of final study report28/07/2023
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)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Sex
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects1000000
Additional information
The source population will include data from 9 data sources in 8 European countries, comprising 113 million individuals and approximately 1 million pregnancies per year, depending on the in- and exclusion criteria that will differ for each objective the study cohorts.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
SNDS, France
Norwegian Registries, Norway
VID, Spain
PRECOVID study and EpiChron cohort, Spain
Swedish registries, Sweden
Sources of data
Prospective patient-based data collection
Disease/case registry
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Exposure registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Risk assessment
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To estimate prevalence of medicines use in pregnant COVID-19 patients and to describe severity of clinical outcomes as well as pregnancy and neonatal outcomes
Are there primary outcomes?Yes
Use of medication
Severity of COVID-19
Pregnancy and neonatal outcomes
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Case-control study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
The women will be followed up from last menstrual period until the end of pregnancy
15. Data analysis plan
Please provide a brief summary of the analysis method
Descriptive analysis, matched analysis of cohorts and sensitivity analysis will be conducted.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Hurley, Eimir, Sturkenboom, Miriam, Poblador-Plou, Beatriz, Sanfelix-Gimeno, Gabriel, Sanchez, Francisco, Hurtado, Isabel, Rodriguez, Clara, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Bartolini, Claudia, Limoncella, Giorgio, Gini, Rosa, & Nordeng, Hedvig. (2021). COVID-19 infection and medicines in pregnancy – a multinational registry based study Medication use in pregnant women with COVID-19: an interim report. Zenodo. https://doi.org/10.5281/zenodo.5775644https://doi.org/10.5281/zenodo.5775644
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Submitted
