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

Background: The objectives of this study were to evaluate the full impact of SARS-CoV-2 in pregnancy to inform testing strategies, examine the factors that impede testing during pregnancy, and use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy and prenatal care during the pandemic.

Materials/Methods: This study prospectively enrolled two cohorts of pregnant women: exposed (SARS-CoV-2 positive) and unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enrolled as unexposed but later tested positive for SARS-CoV-2 antibodies, crossed over to the exposed cohort. Data were collected via surveys and semi-structured interviews from patients and providers, and the study assessed risk of preterm birth and mother-to-fetus SARS-CoV-2 transmission.

Outcome/Impact: This study filled knowledge gaps on the impact of SARS-CoV-2 infection and current utilization of diagnostic testing in pregnancy. In addition, the study created implementation strategies to overcome barriers to testing, increase uptake, and promote acceptance and sustainability of testing. Furthermore, this study helped determine optimal testing strategies by examining the necessity of testing for asymptomatic disease, informed prenatal care plans by assessing the full impact of infection, and contributed to the ability to counsel women and create prenatal care plans if they were pregnant or considering pregnancy.

研究背景：本研究旨在全面评估新型冠状病毒（SARS-CoV-2）感染对妊娠的影响，为新冠病毒检测策略制定提供科学依据；剖析妊娠期间阻碍新冠病毒检测实施的各类因素；并依托研究数据，设计可优化大流行期间妊娠人群新冠病毒检测及产前保健（prenatal care）服务的落地实施策略。
材料与方法：本研究前瞻性纳入两个妊娠女性队列：暴露组（新型冠状病毒（SARS-CoV-2）检测阳性）与非暴露组（以妊娠初始阶段、各妊娠周期（每三个月为一个周期）及分娩时的抗体检测结果均为阴性作为判定标准）。最初纳入非暴露组但后续新型冠状病毒抗体检测转阳的受试者，将转入暴露组。研究通过对受试者及医护人员开展问卷调查与半结构化访谈收集数据，并评估早产发生风险以及新型冠状病毒母婴传播风险。
研究结果与意义：本研究填补了妊娠人群新型冠状病毒感染影响及当前诊断检测应用现状相关的知识空白。此外，本研究制定了可突破检测阻碍、提升检测覆盖率与参与度、增强检测接受度与可持续性的实施策略。进一步而言，本研究通过评估无症状感染者的检测必要性，明确了最优检测策略；通过全面评估感染对妊娠的全维度影响，为产前保健方案制定提供科学支撑；同时可为妊娠女性或备孕女性提供专业咨询，并辅助其制定个性化产前保健计划。