View Study

Status: Planned First registered on: 31/03/2021

Last updated on: 29/09/2022

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 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

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?24

UMCU

Utrecht University Pharmacoepidemiology Center

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

- 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)

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

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.

16. ENCePP seal

Are you requesting the ENCePP seal for this study? No

17. Full protocol

Document Deliverable 2b by the EU PE&PV research network for the CONSIGN project version1.1_20210312.pdf

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

É. Maisonneuve, O. de Bruin, E. Hurley, H. Nordeng, S.J. Siiskonen, F. Ahmadizar, J. Lyons, E. Messenger-Jones, A. Bérard, K.W.M. Bloemenkamp, A.J.M. Aabakke, E. Oakley, K. Woodworth, N. Al-Fadel, & M.C.J.M. Sturkenboom. (2022). CONSIGN-International Meta-analysis Protocol & Statistical Analysis Plan (1.1). Zenodo. https://doi.org/10.5281/zenodo.7112747https://doi.org/10.5281/zenodo.7112747

19. Other relevant documents

Conflict(s) of interest of investigator(s)Not submitted

Composition of Steering Group and ObserversNot submitted

1. Study identification

2. Research centres and Investigator details

Coordinating study entity

Details of (Primary) lead investigator

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Countries in which this study is being conducted

3. Study timelines: initial administrative steps, progress reports and final report

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

5. Contact details for enquiries

Scientific Enquiries

Public Enquiries

6. Study drug(s) information

7. Medical conditions to be studied

8. Population under study

9. Number of subjects

10. Source of data

11. Scope of the study

12. Main objective(s)

13. Study design

14. Follow-up of patients

15. Data analysis plan

16. ENCePP seal

17. Full protocol

18. Study Results

19. Other relevant documents