The COVID-19 Ontario Pregnancy Event (COPE) Network: Assessing the impact of COVID-19 in pregnancy on maternal, fetal and newborn health [Added supplement: COVID-19 Variant Supplement]

In order to assess the mother-to-infant and potential vertical transmission of SARS-CoV-2 infection in pregnant women, maternal and neonatal biological samples will be prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals across Ontario. Samples will be tested for the SARS-CoV-2 serology and viral load. The study population will consist of pregnant women with confirmed or suspected COVID-19 at any point during pregnancy, who will be delivering at a participating hospital within Ontario and agree to provide maternal and/or neonatal samples. Outcomes for the study objective will be ascertained through the collection and testing of biological samples from the mother and/or infant. Specifically we will: 1) Assess vaginal mucosa, amniotic fluid, placenta, breastmilk, cord blood and neonatal nasopharyngeal swab for RNA particles of SARS-CoV-2, by ddPCR. 2) Examine the impact of SARS-CoV-2 impact on neonate with respect to serology and viral load, in addition to placenta pathology findings and ddPCR. 3) Assess vertical transmission and the effect of SARS-CoV-2 through placental pathology examina