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
Website/Homepagewww.umcutrecht.nl
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

UMCU
Utrecht University Pharmacoepidemiology Center
BIPS GmbH
Aarhus University Dept. of Clinical Epidemiology
RTI-HS
ARS
Bordeaux PharmacoEpi
FICF
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) 
Email address m.c.j.sturkenboom@umcutrecht.nl
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) 
Email address m.c.j.sturkenboom@umcutrecht.nl 
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