A global registry of women affected by COVID-19 in pregnancy, understanding natural history to guide treatment and prevention

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. BACKGROUND. In the current COVID outbreak, there are case reports with variable outcomes reported for 18 women affected by nCoV in the third trimester, 50% delivered pre-term but there were no reports of vertical transmission. Therefore there are significant knowledgegaps regarding the impact of COVID-19 on mothers' and babies' health at all stages of pregnancy, including delivery and neonatal care, due to lack of primary data. SARS and MERS resulted in >25% case fatality in pregnant women, with worse effects in those infected in earlier pregnancy. AIMS To understand the natural history of COVID-19 in pregnancy, in order to guide treament and prevention during the outbreak. DELIVERABLES Registry: We will construct a registry of women affected by COVID-19 during pregnancy, detailing presenting symptoms, clinical course, key diagnostic testing modalities and pathology results, adverse pregnancy outcomes, including vertical transmission, perinatal and neonatal outcomes. Pseudonymised data will be entered by health professionals via a password-protected web portal; the database will be hosted in an established clinical trials unitwith a study co-ordinator, senior data manager and statistician. We have a network of collaborators across Europe, China and USA to identify cases from these areas. Our senior project-partners in China and Hong Kong have expertise in women and children's health and epidemiology and will facilitate case reporting in areas which have a high prevalence of COVID-19 . This registry will be used to produce weekly online reports of aggregated, anonymised data during the outbreak to inform treatment and prevention during the outbreak, within the period of the grant. Data sharing (for pseudonymised individual participant data) will be made available for ethically approved research during and after the outbreak.