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Understanding the varied impact of COVID-19 severity on pregnancy outcomes is crucial for informed clinical management and targeted interventions. While existing studies have shed light on the association between COVID-19 and adverse pregnancy outcomes, many have not systematically stratified their analyses based on disease severity. Recognizing this gap in knowledge, our international collaborative effort, the COVID-19 infection and medicines in pregnancy (CONSIGN) project, undertaken within the EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network and funded by the European Medicines Agency (EMA), aimed at elucidating the relationship between COVID-19 severity and pregnancy-related adverse outcomes.
Within the CONSIGN project, we conducted a prospective two-stage individual participant data (IPD) meta-analysis of studies with similar protocols and settings that utilized secondary data. Our objective was to assess the impact of COVID-19 on pregnancy-related outcomes, distinguishing between pregnant women managed in primary care and those needing hospital admission.