International collaboration to study the impact of Covid-19 and medicines on pregnancy, maternal and neonatal outcomes

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 ConcePTION consortium, which was established under the EU’s Innovative Medicines Initiative, the COVI-PREG project and the International Network of Obstetric Survey Systems (INOSS) network.

In its CONSIGN-International document, the Consortium describes ongoing initiatives and opportunities for international collaboration in the area of medicines use and their effects on management of COVID-19 in pregnancy. Such collaboration is open to any researchers who wish to participate. For further information, please contact m [dot] c [dot] j [dot] sturkenboomumcutrecht [dot] nl (Prof. Miriam Sturkenboom).

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.

Related information:

• CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
• Registry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study)
• COVID-19 infections and medicines in pregnancy- the INOSS collaboration