Status: Planned
First registered on:
31/03/2021
Last updated on:
18/02/2022
1. Study identification
EU PAS Register NumberEUPAS40317
Official titleDescription of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))
Study title acronymCONSIGN-International
Study typeOther: Description of international collaboration
Brief description of the studyThis 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 EU PAS register includes a general description of international collaboration. A meta-analysis of existing data collections is currently under discussion and details will be added as soon as a concrete study plan is available.
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 to which the investigator belongsUMCU
Department/Research group
Organisation/affiliationUniversity Medical Center Utrecht
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
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?17
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
Countries in which this study is being conducted
International study
Denmark
Germany
Italy
Netherlands
Norway
Spain
Sweden
Switzerland
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 expected15/07/2022
Date of final study report17/07/2023
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 Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2
Address line 3
CityUtrecht
Postcode
CountryNetherlands
Phone number (incl. country code)31657831983
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2
Address line 3
CityUtrecht
Postcode
CountryNetherlands
Phone number (incl. country code)31657831983
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
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Adults (18 - 44 years)
Sex
Female
Other population
Pregnant women
9. Number of subjects
Estimated total number of subjects1000000
Additional information
This is a description of international collaboration
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
In chapter 2, we list and describe many individual initiatives and networks plus opportunities for collaboration based on 1) secondary use of health care data, which will mostly capture outpatient treatment, and 2) based on primary data collection from health clinics.
11. Scope of the study
What is the scope of the study?
International collaboration
Primary scope : International collaboration
12. Main objective(s)
What is the main objective of the study?
Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies with two key objectives
1) Use of medicines to treat COVID-19 in pregnancy
2) Effects of medicines used to treat COVID-19 in pregnancy on pregnancy, perinatal and neonatal outcomes.
Are there primary outcomes?Yes
Maternal, obstetrical and neonatal outcomes
Are there secondary outcomes?No
13. Study design
What is the design of the study?
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
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
In chapter 3, we summarize the proposal to move forward and the potential approaches. CONSIGN-international will focus on two key objectives
1) Use of medicines to treat COVID-19 in pregnancy
2) Effects of medicines used to treat COVID-19 in pregnancy on pregnancy, perinatal and neonatal outcomes.
Based on our review and to our best knowledge no initiative is specifically focusing on the impact of medicines in COVID-19 affected pregnancies, and collaboration would have great benefits to learn more about the treatments used and their effects on pregnancy outcomes.
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
Sturkenboom, MCJM, Nordeng, H, Klungel, O, Margulis, A, Poblador, D, Siiskonen, SJ, Perez-Gutthann, S, Gardarsdottir, H, Rivero, E, Jordan, S, Lupatelli, A, Franzoni, C, Engjbom, H, & Andersen, M. (2021). Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (1.1). Zenodo. https://doi.org/10.5281/zenodo.5211395https://zenodo.org/communities/consign/
de Bruin, O; Maisonneuve, E; Sturkenboom, MCJM. Description and characterization of the data sources to be included in the CONSIGN-International meta-analysishttps://doi.org/10.5281/zenodo.6127384
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
Not submitted
