Safety, Testing/Transmission, and Outcomes in Pregnancy with COVID-19 (STOP-COVID-19 study)

ABSTRACTIn response to NOT-OD-20-120, we submit this competitive revision of grant # R01 HD091218 04(Mechanisms of Zika Virus Maternal-Fetal Transmission) to investigate the impact of COVID-19 and testing forthe causative virus, SARS-CoV-2, among pregnant women and their infants. Pregnant women are a vulnerableand high-risk population, as COVID-19 is associated with an increased risk of preterm birth, cesarean section,and maternal intensive care. The objectives of this study are to: (a) evaluate the full impact of SARS-CoV-2 inpregnancy to inform testing strategies, (b) examine the factors that impede testing during pregnancy, and (c)use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy andprenatal care during the pandemic. To do so, we propose to prospectively enroll two cohorts of pregnantwomen: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibodytesting at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll asunexposed but later test positive for SARS-CoV-2 antibodies will cross over to the exposed cohort. In total, anestimated 179 pregnant women will be followed per cohort. In Aim 1, we will evaluate patients' and providers'perceptions of SARS-CoV-2 testing during pregnancy and the influence of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured interviews. We hypothesize suboptimal uptakeof testing among pregnant women due to the fear of repercussions from a positive test. In Aim 2, we willdetermine the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adversepregnancy outcomes in symptomatic and asymptomatic disease. We hypothesize that SARS-CoV-2 infectionwill increase the risk of preterm birth by 12%, regardless of disease severity. In Aim 3, we will estimate the risk of mother-to-fetus SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic fluid by assaying for viral RNA in the neonate, cord blood, and placenta. We hypothesize that SARS-CoV-2 can be transmitted from mother to fetus. Collectively, Aims 1-3 will be interpreted by investigators, ourScientific Advisory Board (experts in obstetrics, infectious disease, implementation science, disparities) andour Community Advisory Board (an obstetric social worker, pregnant women, and a director of a communityobstetrics clinic) who will apply data to devising targeted implementation strategies designed for rapidcommunity dissemination to improve testing and prenatal care. In sum, this study will fill knowledge gaps onthe impact of SARS-CoV-2 infection and current utilization of diagnostic testing in pregnancy. Further, it willcreate implementation strategies to overcome barriers to testing, increase uptake, and promote acceptanceand sustainability of testing. Lastly, this study will help determine optimal testing strategies by examining thenecessity of testing for asymptomatic disease, inform prenatal care plans by assessing the full impact ofinfection, and contribute to our ability to counsel women and create prenatal care plans if they are pregnant orconsidering pregnancy.