Influenza & COVID Obstetric and Perinatal Epidemiology Study in India

2019冠状病毒病（COVID-19）由严重急性呼吸系统综合征冠状病毒2（SARS- CoV-2）于2019年12月在中国湖北省武汉市首次报告，到2021年初， 全球新冠肺炎病例已超过1亿例。COVID-19对孕妇的影响 在高收入/中上收入国家，正在进行深入调查。几乎没有类似的研究， 低/中低收入国家（LMIC）和高收入国家的COVID-19感染数据可能不 可以推广到LMIC。鉴于世界上大量的出生发生在低收入国家， 需要了解COVID-19（和其他呼吸道病毒（ORV），特别是流感）对孕妇的风险 妇女和新生儿。我们的团队最近领导了疾病控制和预防中心的印度网站 关于实验室确诊流感对3个低收入国家孕妇的影响的研究，发现流感是 与晚期妊娠丢失和平均出生体重降低有关。利用这个最近完成的研究 和10年来在印度中部每年研究约10，000名孕妇的经验，我们现在提出 《印度流行性感冒及新冠肺炎产科及围产期流行病学研究》（Influenza & COVID Obstetric and Perinatal Epidemiology Study in India）ICOPE将招收10，000人 孕妇到印度纳格布尔的一家大型产科医院做产前检查。重要特征 我们的研究包括：（i）记录的能力，招募妇女在怀孕的头三个月（超声 确诊）;（ii）每周两次随访COVID-19/ORV/流感症状，结合实验室检测 对于有症状和无症状感染（逆转录聚合酶链反应检测， 在怀孕期间经常采集干血斑以检测COVID IgG和IgM） 产后第7天。重症新生儿将接受COVID-19和流感评估， 将在出生后第7天采集血液样本检测COVID抗体。新冠肺炎孕妇入院 将获得样本以评估炎性细胞因子的轨迹。我们会对干血进行生物样本库 为未来的研究提供了点。我们的具体目标是：（1）确定患病率，发病率和最大严重程度 有症状或无症状的COVID-19在孕妇产后第7天，以及是否流感/ORV 感染或疫苗接种改变和早产介导这种风险;（2）确定母亲的影响， 胎儿和/或新生儿至生命第7天的COVID-19感染;以及流感/ORV或疫苗接种 修改和早产介导这种风险;（3）表征模式和轨迹的主机 作为COVID-19±流感感染的潜在介质， 患有COVID-19的孕妇/母亲的严重疾病。修饰物包括疫苗接种。ICOPE是 我们有能力提供有关COVID-19和ORV在所有妊娠期随时间推移的影响的信息， 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.