Influenza & COVID Obstetric and Perinatal Epidemiology Study in India

流感

• 批准号: 10535602
• 负责人: Patricia L Hibberd
• 金额: $ 56.85万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10535602
• 关键词: 2019-nCoV; Acute-Phase Proteins; Address; Antibodies; Biological Markers; Birth; Blood; COVID-19; COVID-19 impact; COVID-19 patient; COVID-19 risk; COVID-19 severity; Centers for Disease Control and Prevention (U.S.); Child; China; Cohort Studies; Collaborations; Collection; Communicable Diseases; Country; Critical Illness; Data; Discipline of obstetrics; Disease; Emergency Situation; Enrollment; Fetus; First Pregnancy Trimester; Funding; Future; Hospitalization; Hospitals; Immune response; Immunoglobulin G; Immunoglobulin M; Incidence; Income; India; Infection; Inflammatory; Inflammatory Response; Influenza; Intensive Care; Investigation; Joints; Laboratories; Late pregnancy; Life; Maternal Mortality; Mediating; Mediator of activation protein; Mothers; National Institute of Child Health and Human Development; Neonatal; Newborn Infant; Observational Study; Outcome; Pattern; Perinatal Epidemiology; Perinatal mortality demographics; Polymerase Chain Reaction; Positioning Attribute; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnancy loss; Pregnant Women; Premature Birth; Premature Labor; Prevalence; Prevention; Province; Public Health; Publications; Readiness; Reporting; Resource-limited setting; Respiratory Signs and Symptoms; Reverse Transcription; Risk; Risk Factors; SARS-CoV-2 infection; Seasons; Severities; Site; Specimen; Spottings; Symptoms; Tablets; Testing; Time; Update; Vaccination; Vaccines; Visit; Woman; antenatal care; asymptomatic COVID-19; at-risk pregnancies; base; biobank; breakthrough infection; cohort; coronavirus disease; cytokine; epidemiology study; experience; fetal; follow-up; influenza infection; influenzavirus; low and middle-income countries; maternal outcome; maternal risk; mortality; nasopharyngeal swab; neonate; offspring; perinatal outcomes; primary outcome; recruit; respiratory infection virus; respiratory virus; secondary analysis; ultrasound; variants of concern

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.

由严重急性呼吸系统综合症冠状病毒 2（SARS- CoV-2）于 2019 年 12 月在中国湖北省武汉市首次报道，到 2021 年初，已有 全球有超过 1 亿例 COVID-19 病例，COVID-19 对孕妇的影响。 高收入/中高收入国家的相关研究正在进行深入调查，但很少有平行研究。 低/中低收入国家 (LMIC) 和高收入国家的 COVID-19 感染数据可能不会 鉴于世界上大量出生人口发生在中低收入国家，因此迫切需要解决这一问题。 需要了解 COVID-19（和其他呼吸道病毒 (ORV)，特别是流感）对怀孕的风险 我们的小组最近领导了疾病控制和预防中心的印度站点。 关于实验室确诊的流感对 3 个中低收入国家孕妇的影响的研究发现，流感 与晚期妊娠流产和平均出生体重降低有关。 以及 10 年在印度中部每年研究约 10,000 名孕妇的经验，我们现在提出 “印度的流感和新冠肺炎产科和围产期流行病学 (ICOPE) 研究将招募 10,000 人。” 孕妇到印度那格浦尔一家大型产科医院接受产前护理。 我们的研究包括：（i）有记录的在怀孕前三个月招募女性的能力（超声波 (ii) 每周两次对 COVID-19/ORV/流感症状进行随访，并结合实验室检测 针对有症状和无症状感染（逆转录聚合酶链反应检测 怀孕期间鼻咽拭子和频繁采集干血斑以检测新冠病毒 (COVID-19) IgG 和 IgM) 产后第 7 天，患有危重疾病的新生儿将接受 COVID-19 和流感评估并进行干燥。 患有 COVID-19 的孕妇将在出生后第 7 天采集血斑以检测 COVID-19 抗体。 我们将获得样本来评估炎症细胞因子的轨迹，我们将对干燥的血液进行生物银行。 我们未来研究的具体目标是：（1）确定患病率、发生率和最大严重程度。 孕妇至产后第 7 天有症状或无症状的 COVID-19 的发生率，以及是否患有流感/ORV 感染或疫苗接种会改变和早产介导这种风险（2）确定母亲的影响； 胎儿和/或新生儿至出生后第 7 天的 COVID-19 感染以及是否流感/ORV 或疫苗接种； 改变和早产介导这种风险；（3）表征宿主的模式和轨迹； 反应/炎症生物标志物作为 COVID-19±流感感染进展的潜在介质 患有 COVID-19 的孕妇/母亲患有严重疾病，修饰语包括接种 ICOPE。 能够很好地提供有关 COVID-19 和 ORV 在整个妊娠期随时间推移的影响的信息 LMIC 设置。