Influenza & COVID Obstetric and Perinatal Epidemiology Study in India

由严重急性呼吸系统综合症冠状病毒2引起的冠状病毒病2019年(新冠肺炎) CoV-2)于2019年12月在湖北省武汉市首次报告中国，到2021年初，已有 在全球范围内，新冠肺炎的案例已经超过1亿。新冠肺炎对孕妇的影响 在高/上中等收入国家，正在进行深入的调查。几乎没有类似的研究 低/低中等收入国家和高收入国家新冠肺炎感染的数据可能不会 可推广到LMIC。鉴于世界上发生在LMIC的大量新生儿，有一个紧迫的问题 需要了解新冠肺炎(和其他呼吸道病毒，特别是流感)对孕妇的风险 妇女和新生儿。我们小组最近领导了印度疾病控制和预防中心的网站 3个LMICs实验室确诊的流感对孕妇影响的研究，发现流感 与妊娠晚期丢失和平均出生体重降低有关。利用这项最近完成的研究 以及10年来在印度中部每年研究约10,000名孕妇的经验，我们现在建议 “印度的流感和柯萨奇病毒产科和围产期流行病学研究。”ICope将招收10,000人 在印度那格浦尔一家大型产科医院接受产前护理的孕妇。重要特征 我们的研究包括：(I)有记录的在怀孕前三个月招募妇女的能力(超声波 确诊)；(2)每周两次新冠肺炎/口服呼吸道合胞病毒/流感症状的随访，结合实验室检测 用于有症状和无症状的感染(逆转录聚合酶链式反应检测 妊娠期间的鼻咽拭子和频繁采集干血斑点检测柯萨奇病毒免疫球蛋白和免疫球蛋白 直到产后第7天。对危重新生儿进行新冠肺炎和流感评估，并烘干 将在生命的第7天采集血斑以检测柯萨奇病毒抗体。孕妇感染新冠肺炎入院治疗 将获得样本以评估炎性细胞因子的轨迹。我们会将干血存入生物库 未来研究的热点。我们的具体目标是：(1)确定患病率、发病率和最大严重程度 有症状或无症状新冠肺炎的孕妇至产后第7天以及流感/口蹄疫 感染或接种疫苗会改变这种风险，并通过早产来调节；(2)确定母婴传播的影响。 胎儿和/或新生儿至出生第7天感染新冠肺炎；以及是否接种流感/ORV病毒或疫苗 修改和调节早产的风险；(3)描述宿主的模式和轨迹 反应/炎症生物标记物作为新冠肺炎±流感感染进展的潜在介质 接受新冠肺炎治疗的孕妇/母亲患有严重疾病。修饰因素包括接种疫苗。ICope是 能够提供有关新冠肺炎和ORV在所有三个月的一段时间内的影响的信息 LMIC设置。

Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS- CoV-2) was first reported in Wuhan, Hubei Province of China in December 2019 and by early 2021, there have been more than 100 million cases of COVID-19 globally. The consequences of COVID-19 in pregnant women in high/upper middle-income countries are under intensive investigation. There are few parallel studies in low/lower middle- income countries (LMIC) and data on COVID-19 infection in high-income countries may not be generalizable to LMIC. Given the large number of the world’s births that occur in LMIC, there is an urgent need to understand the risk of COVID-19 (and other respiratory viruses (ORV), particularly influenza) to pregnant women and newborns. Our group recently led the Indian site of the Centers for Disease Control and Prevention study on the impact of laboratory confirmed influenza in pregnant women in 3 LMICs, finding that influenza was associated with late pregnancy loss and reduced mean birthweight. Leveraging this recently completed study and 10 years of experience of studying ~10,000 pregnant women a year in Central India, we now propose the “Influenza & COVID Obstetric and Perinatal Epidemiology (ICOPE) Study in India.” ICOPE will enrol 10,000 pregnant women presenting to a large obstetric hospital in Nagpur, India for antenatal care. Important features of our study include: (i) documented ability to recruit women in the first trimester of pregnancy (ultrasound confirmed); (ii) twice weekly follow-up for COVID-19/ORV/Influenza symptoms, combined with laboratory testing for symptomatic and asymptomatic infection (reverse transcription–polymerase chain reaction testing of nasopharyngeal swabs and frequent collection of dried blood spots for COVID IgG and IgM) during pregnancy through day 7 post-partum. Neonates with critical illness will be assessed for COVID-19 and influenza and dried blood spots will be obtained for COVID antibodies on day 7 of life. Pregnant women admitted with COVID-19 will have specimens obtained to evaluate trajectories of inflammatory cytokines. We will biobank dried blood spots for future studies. Our specific aims are to: (1) determine the prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 7 postpartum and whether influenza/ORV infection or vaccination modifies and pre-term birth mediates this risk; (2) determine the effect of maternal COVID-19 infection on the fetus and/or neonate to day 7 of life; and whether influenza/ORV or vaccination modifies and pre-term birth mediates this risk; (3) characterize patterns and trajectories of host response/inflammatory biomarkers as potential mediators of COVID-19±influenza infection on progression to severe illness in pregnant women/mothers admitted with COVID-19. Modifiers include vaccination. ICOPE is well positioned to provide information on the impact of COVID-19 and ORV, across all trimesters, over time in a LMIC setting.