A prospective cohort study investigating maternal, pregnancy and neonatal outcomes for women and neonates infected with SARS-CoV-2

Generic protocol This protocol outlines a prospective cohort study investigating the outcomes of pregnant or recently pregnant women infected with SARS-CoV-2 (exposed) compared to pregnant or recently pregnant women not infected with SARS-CoV-2 during pregnancy (unexposed). The purpose of this study is to determine if SARS-CoV-2 infection during pregnancy increases the risk of adverse pregnancy, postpartum or neonatal outcomes. Additionally, the study characterizes the clinical spectrum of COVID-19 in pregnant women, quantify (if any) the rate of in utero/intrapartum/postnatal transmission, determine the incidence of detectable SARS-CoV-2 RNA in pregnancy-related fluids (i.e. amniotic fluid), breast milk and tissues, and follow clinical outcomes of women and their newborns up to 6 weeks after childbirth.