Global Network for Women's and Children's Health Research Data Coordinating Center

全球妇女和儿童健康网络研究数据协调中心

• 批准号: 10348262
• 负责人: Elizabeth M McClure
• 金额: $ 24.15万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-10 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10348262
• 关键词: Antibodies; Bangladesh; Blood specimen; COVID-19; Child Health; Cohort Studies; Consent; Data Coordinating Center; Enrollment; Fetal Growth Retardation; Guatemala; Health Knowledge, Attitudes, Practice; India; International; Kenya; Low Birth Weight Infant; Maternal Health; Methodology; National Institute of Child Health and Human Development; Neonatal Mortality; Newborn Infant; Observational Study; Outcome; Pakistan; Population; Postpartum Period; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Prevalence; Registries; Research; SARS-CoV-2 antibody; Sampling; Site; Testing; Visit; Woman; Zambia; antenatal care; antibody test; fetal; low and middle-income countries; neonatal health; neonatal outcome; population based; pregnant; prospective; stillbirth

The aim of the “COVID-19 prevalence during pregnancy and pregnancy outcomes in 8 LMIC: A Global Network for Women's and Children's Health” study is to determine the prevalence of COVID-19 antibodies in pregnant /recently delivered women in 8 Global Network sites (in DRC, Kenya, Zambia, Bangladesh, India [2 sites], Pakistan and Guatemala) and its association with pregnancy outcomes. RTI International serves as the study data coordinating center. Specifically, the study will determine the prevalence of COVID-19 antibodies in pregnant/recently delivered women in 8 Global Network sites using antibody testing; compare the maternal, fetal and neonatal outcomes of COVID-19 antibody positive women vs. antibody negative women (low birth weight, preterm birth, fetal growth restriction, stillbirth and neonatal mortality); and will assess knowledge, attitudes and practices of pregnant women related to COVID-19 during pregnancy. This will be a prospective, population-based, cohort study conducted of 20,000 women which will be conducted within the Global Network's Maternal and Newborn Health Registry (MNHR), a population-based observational study, over a 12-month study period. Following enrollment in the MNHR, women will be requested to consent for the COVID- 19 study which may include a blood sample collected at first antenatal care visit (4 sites) and/or at delivery (all sites). All women enrolled will also have pregnancy outcomes collected at delivery and 6-weeks postpartum. Maternal samples will be assessed for COVID-19 antibodies, using the same testing analyses methodology across all study sites, coordinated and supported through RTI International. Analyses will be conducted to assess the prevalence of COVID-19 antibodies in the population, and to assess the association of antibodies with maternal and newborn outcomes.

“妊娠期间 COVID-19 患病率和妊娠结局的目标是 8 LMIC：全球妇女和儿童健康网络”研究旨在确定 全球 8 个地区孕妇/刚分娩的妇女中 COVID-19 抗体的流行情况 网络站点（刚果民主共和国、肯尼亚、赞比亚、孟加拉国、印度 [2 个站点]、巴基斯坦和 危地马拉）及其与妊娠结局的关系。 具体来说，研究数据协调中心将确定患病率。 8 个全球网络站点中孕妇/刚分娩的妇女中的 COVID-19 抗体 使用抗体检测；比较 COVID-19 的孕产妇、胎儿和新生儿结局 抗体阳性女性与抗体阴性女性（低出生体重、早产、 胎儿生长受限、死产和新生儿死亡率）；并将评估知识， 孕妇在怀孕期间对 COVID-19 的态度和做法。 这将是一项以人群为基础的前瞻性队列研究，对 20,000 名女性进行了研究 将在全球网络的孕产妇和新生儿健康登记处进行 (MNHR)，一项为期 12 个月的基于人群的观察性研究。 加入 MNHR 后，将要求妇女同意接受新冠病毒 19 项研究可能包括首次产前保健就诊时采集的血液样本（4 个地点） 和/或分娩时（所有地点）。 将对分娩时和产后 6 周收集的母体样本进行评估。 COVID-19 抗体，在所有研究中使用相同的测试分析方法 分析将通过 RTI International 进行协调和支持。 评估人群中 COVID-19 抗体的流行情况，并评估 抗体与孕产妇和新生儿结局的关联。