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.

“8个国家的COVID-19妊娠期患病率和妊娠结局”的目的是 LMIC：全球妇女和儿童健康网络”研究旨在确定 全球8个国家的孕妇/近期分娩妇女中COVID-19抗体的患病率 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。RTI国际作为 研究数据协调中心。具体来说，这项研究将确定 8个全球网络站点的孕妇/最近分娩的妇女中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 抗体阳性妇女与抗体阴性妇女（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 将是一项前瞻性的、基于人群的、对20,000名女性进行的队列研究， 将在全球网络的孕产妇和新生儿健康登记处内进行 （MNHR）是一项基于人群的观察性研究，为期12个月。 在MNHR注册后，将要求女性同意COVID- 19项研究，可能包括首次产前护理访视时采集的血液样本（4个研究中心） 和/或交付时（所有研究中心）。所有入组的女性也将有妊娠结局 在分娩和产后6周时采集。将评估母体样本的 COVID-19抗体，在所有研究中使用相同的检测分析方法 通过RTI国际组织协调和支持。将进行分析 评估COVID-19抗体在人群中的流行率，并评估 抗体与孕产妇和新生儿结局的相关性。