Objective

• To estimate the prevalence of medicines used, by trimester of pregnancy, and compare this among pregnant women with COVID-19, pregnant women without COVID-19, and non-pregnant women with COVID-19.
• To describe severity and clinical outcomes of COVID-19 disease in pregnant women with COVID-19, according to treatments received during pregnancy, and compare these data with those of non-pregnant women of reproductive age with COVID-19.
• To assess and compare the rates of adverse maternal and neonatal outcomes in pregnant women with and without COVID-19, using different medicines.

Countries

• In the current pandemic, pregnant women are becoming infected with the SARS-CoV-2 virus and being treated for COVID-19 disease and its complications. EMA wishes to be prepared for situations where questions arise regarding the impact of medicine used for COVID-19 during pregnancy, on the unborn child. To answer such questions, insight is needed into drug utilisation in COVID-19 affected pregnancies compared with other pregnancies. The regulatory network will be better placed to judge the appropriateness of use in pregnancy, as well as the appropriateness of any proposed pregnancy-related risk minimisation measures, with better insight into how the disease, and treatments currently used, affect the pregnant woman and her infant.

Funding