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Covid-19 infectiON and medicineS In preGNancy
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The European Medicines Agency has contracted Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’) to collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccination policies and treatment options for COVID-19 in pregnant women.
CONSIGN is analysing existing data sources (e.g. electronic health records, hospital data) and cohorts of pregnant women to provide information on the effect of infection and its treatments in different trimesters of pregnancy and on neonates. The project is being carried out in collaboration with the IMI-ConcePTION consortium, which was established under the EU’s Innovative Medicines Initiative (IMI), the COVI-PREG project and the International Network of Obstetric Survey Systems (INOSS) network.
 
The ultimate goal of this work is to create a global and sustainable infrastructure for prospective benefit-risk monitoring of treatments in pregnancy beyond those used in COVID.
 

The CONSIGN community brings together partners from various estbalished European and global networks that aim to study the impact of COVID-19 disease and medicines use during pregnancy.

It aims to provide robust evidence based on post-marketing data to fill the knowledge gap because pregnant women are not included in phase III trials. CONSIGN is built on bringing together the partnerships with

- the IMI-ConcePTION consortium:  ConcePTION is a project funded by the Innovative Medicines Initiative, a private public partnership. It is building an ecosystem for generating robust evidence on safety of medicines use in pregnancy. CONSIGN is using the evidence generation pipeline on electronic health record data that was developed in ConcePTION WP7

- The COVI-PREG network, an international registry for emergent pathogens and pregnancy: led by University Lausanne. COVI-PREG is built on a well established collaborations with 198 antenatal clinics from 23 countries in Africa, Asia, Europe, Oceania, and the Americas who use a structured data collection tool (REDCAP) available to any facility assessing pregnant patients for SARS-CoV-2 infection.

- The INOSS network: The International Network of Obstetric Survey Systems (INOSS) is a multinational collaboration of organisations conducting prospective population-based studies of serious illnesses in pregnancy and childbirth. The organisations participating in the network conduct high quality studies of these uncommon disorders on a regional, national and international basis with the objective of improving the quality of care for both women and their infants.