Abstract
There is a paucity of data on COVID-19 in pregnancy. The proposed study is designed to provide critical data on the characteristics of the infection in pregnant women by means of a population-based in pregnant and non-pregnant women. The primary objectives are to describe the seroprevalence, clinical spectrum compared with non-pregnant women and perinatal outcomes of COVID-19 in pregnancy. A secondary objective is to evaluate the clinical presentation of COVID-19 with maternal gut microbiota patterns. The sample size was calculated assuming a 15% COVID-19 positive rate. Baseline characteristics, clinical symptoms for COVID-19, obstetrical and perinatal outcome will be collected. In all women, nasopharyngeal (NP) swabs will be obtained for SARS-CoV2 RT-PCR and serum (maternal peripheral blood and cord blood) for SARS-CoV2 IgM and IgG. Neonatal NP swabs and antibodies in cord blood will be evaluated in all SARS-CoV2+ and 1-to-1 matched controls. Rectal swabs in pregnant women SARS-CoV2+ and controls matched 1-to-1 will be used to study the microbiota in relation with clinical presentation. Final results will be available by the end of June 2020. This study will provide important population-based data on the clinical presentation and impact on perinatal outcomes of COVID-19.
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