CONSIGN – Covid-19 infectiOn aNd medicineS In pregnancy
Overarching goal: To provide adequate data on the impact of COVID-19 in pregnancy to guide decision-making about vaccine indications, vaccination policies, and treatment options for COVID-19 disease and associated complications.
Aims of WP1 – Use of linked administrative data based
1) to estimate the prevalence of medicines used, by trimester of pregnancy and compare this between pregnant women with COVID-19, pregnant women without COVID-19 and non-pregnant women with COVID-19.
2) To estimate outcomes of COVID-19 in pregnant and non-pregnant women
3) To compare the rates of maternal and neonatal outcomes in pregnant women with and without COVID-19, using different medicines.
Collectively we can access data from at least 8 countries from northern, southern, western and more eastern Europe which we know can deliver in time as most of them have already converted to the ConcePTION CDM and obtained approvals for data characterization: UK (Swansea) Norway (UiO), Denmark (AUH/Copenhagen), Germany (GePaRD), Spain (FISABIO/Aragon), Italy (ARS), France (SNDS), Sweden. Together we capture data on a source population of more than 100 million subjects with 1 million births per year.
Organization: UiO subcontracted by University Medical Center Utrecht (UMCU), The Netherlands
Funded by the European Medicines Agency
Duration: July 2020 – July 2021