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 EUPAS register includes a general description of international collaboration and a protocol and statistical analysis plan of a meta-analysis of the existing data collections.
Was this study requested by a regulator?No
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 applicableThis is an EMA-tendered study
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?24
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
- George Washington University - SFDA - SET-NET (CDC) - Health Canada - CAMCCO - FDA - Sentinel - University of Lausanne (CHUV), International collaborators
Countries in which this study is being conducted
International study
Belgium
Canada
Denmark
Finland
Germany
Iceland
Italy
Netherlands
Norway
Saudi Arabia
Spain
Sweden
Switzerland
United Kingdom
United States
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 analysis01/09/2022
Date of interim report, if expected31/03/2023
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 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 international collaboration and meta-analysis
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
The sources of data are available at the study sites in collaboration with CONSIGN group.
There are 2 different types of data sources:
1) secondary use of health care data, which will mostly capture outpatient treatment, and
2) case based data collection from health clinics.
11. Scope of the study
What is the scope of the study?
Medicines to treat COVID-19 in pregnant women
Primary scope : Medicines to treat COVID-19 in pregnant women
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 maternal, pregnancy and perinatal outcomes.
Are there primary outcomes?Yes
Maternal, pregnancy and neonatal outcomes
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Meta-analysis divided into 2 sections according to the type of data sources: Meta-analysis #1 on secondary use of health care data, Meta-analysis #2 on case based data collection from health clinics.
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
CONSIGN International will focus on two key objectives:
1) & 2) as stated.
The aim of our international meta-analysis is to describe the use of medicines to treat COVID-19 disease by trimester of pregnancy and the effects of medicines used to treat COVID-19 on maternal, pregnancy and neonatal outcomes and to pool as much data available around the world with similar protocols and settings.
To pool the available data, we will conduct two meta-analyses including prospective and retrospective data collection with reliable data on the different classes of these medicines and associated perinatal outcomes in a real-world clinical setting: the first combining population-based health care data sources (meta-analysis 1) and the second combining case-based registries compiled by health care professionals (meta-analysis 2). For further details regarding the data analysis we refer to our CONSIGN international meta-analysis protocol and statistical analysis plan.