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

摘要 作为对NOT-OD-20-120的回应，我们提交了授权#R 01 HD 091218 04的竞争性修订版 （寨卡病毒母婴传播机制），以调查COVID-19的影响，并检测 在孕妇及其婴儿中发现了SARS-CoV-2的致病病毒。孕妇是一个脆弱的 和高风险人群，因为COVID-19与早产、剖宫产的风险增加有关， 产妇重症监护本研究的目的是：（a）评估SARS-CoV-2对 怀孕，以告知测试策略，（B）检查阻碍怀孕期间测试的因素，以及（c） 利用研究数据制定实施策略，改善妊娠期SARS-CoV-2检测， 在大流行期间提供产前护理。为了做到这一点，我们建议前瞻性地招募两组孕妇， 女性：1）暴露（SARS-CoV-2阳性），2）未暴露（SARS-CoV-2阴性，由抗体定义 在怀孕初期、每三个月和分娩时进行检测）。最初登记为 未暴露但后来SARS-CoV-2抗体检测呈阳性的患者将交叉至暴露队列。总的来说， 估计每个队列将随访179名孕妇。在目标1中，我们将评估患者和提供者的 对妊娠期间SARS-CoV-2检测的看法以及COVID-19对孕产妇护理的影响- 通过调查和半结构化访谈寻求行为和焦虑。我们假设吸收不佳 由于担心检测呈阳性的后果，孕妇不愿接受检测。在目标2中，我们将 确定怀孕期间SARS-CoV-2感染对早产风险和其他不良反应的影响。 有症状和无症状疾病的妊娠结局。我们假设SARS-CoV-2感染 将使早产风险增加12%，无论疾病严重程度如何。在目标3中，我们将评估风险 母亲向胎儿传播SARS-CoV-2和病毒存在于脐带血，胎盘， 通过测定新生儿、脐带血和胎盘中的病毒RNA检测羊水。我们假设SARS- CoV-2可以从母亲传播给胎儿。总的来说，目标1-3将由研究者解释，我们的 科学咨询委员会（产科、传染病、实施科学、差异方面的专家）和 我们的社区咨询委员会（产科社会工作者，孕妇和社区主任） 产科诊所），他们将应用数据制定有针对性的实施战略， 社区传播，以改善检测和产前护理。总之，这项研究将填补知识空白， SARS-CoV-2感染的影响和目前妊娠诊断检测的使用情况。此外，它将 制定实施战略，以克服测试障碍，提高接受率，并促进接受 和测试的可持续性。最后，本研究将有助于确定最佳的测试策略， 无症状疾病检测的必要性，通过评估 感染，并有助于我们的能力，咨询妇女和创造产前护理计划，如果他们怀孕或 考虑到怀孕。

ABSTRACT In 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 for the causative virus, SARS-CoV-2, among pregnant women and their infants. Pregnant women are a vulnerable and 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 in pregnancy 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 and prenatal care during the pandemic. To do so, we propose to prospectively enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies will cross over to the exposed cohort. In total, an estimated 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 uptake of testing among pregnant women due to the fear of repercussions from a positive test. In Aim 2, we will determine the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic and asymptomatic disease. We hypothesize that SARS-CoV-2 infection will 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, our Scientific Advisory Board (experts in obstetrics, infectious disease, implementation science, disparities) and our Community Advisory Board (an obstetric social worker, pregnant women, and a director of a community obstetrics clinic) who will apply data to devising targeted implementation strategies designed for rapid community dissemination to improve testing and prenatal care. In sum, this study will fill knowledge gaps on the impact of SARS-CoV-2 infection and current utilization of diagnostic testing in pregnancy. Further, it will create implementation strategies to overcome barriers to testing, increase uptake, and promote acceptance and sustainability of testing. Lastly, this study will help determine optimal testing strategies by examining the necessity of testing for asymptomatic disease, inform prenatal care plans by assessing the full impact of infection, and contribute to our ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.