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中文摘要
翻译
8年孕期新冠肺炎患病率和妊娠结局的目标 LMIC:一个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/新近分娩妇女新冠肺炎抗体流行率 网络站点(在刚果民主共和国、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国际公司担任 研究数据协调中心。具体地说,该研究将确定患病率 全球8个网络站点孕妇/新近分娩妇女新冠肺炎抗体水平 使用抗体检测;比较新冠肺炎的母体、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, 孕期孕妇对新冠肺炎的态度和行为。这 将对20,000名女性进行前瞻性、基于人群的队列研究, 将在全球网络的产妇和新生儿健康登记处内进行 (MNHR),一项基于人群的观察性研究,为期12个月。 在MNHR登记后,妇女将被要求同意参加COVID- 19项研究,可能包括首次产前检查时采集的血液样本(4个地点) 和/或在交付时(所有站点)。所有登记的女性也将有怀孕结果。 在分娩时和产后6周收集。产妇样本将被评估为 新冠肺炎抗体,在所有研究中使用相同的测试分析方法 通过RTI国际组织进行协调和支持。将进行分析 评估人群中新冠肺炎抗体的流行率,并评估 抗体与孕产妇和新生儿结局的关系。
英文摘要
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.
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Global Network for Women's and Children's Health Research Data Coordinating Center
  • 批准号:
    10583194
  • 项目类别:
  • 资助金额:
    $163.0万
  • 财政年份:
    2022
  • 负责人:
    Elizabeth M McClure
  • 依托单位:
Global Network for Women's and Children's Health Research Data Coordinating Center
  • 批准号:
    10474098
  • 项目类别:
  • 资助金额:
    $50.0万
  • 财政年份:
    2021
  • 负责人:
    Elizabeth M McClure
  • 依托单位:
Global Network for Women's and Children's Health Research Data Coordinating Center
  • 批准号:
    9338976
  • 项目类别:
  • 资助金额:
    $171.3万
  • 财政年份:
    2017
  • 负责人:
    Elizabeth M McClure
  • 依托单位:
Global Network for Women's and Children's Health Research Data Coordinating Center
  • 批准号:
    10744384
  • 项目类别:
  • 资助金额:
    $169.86万
  • 财政年份:
    2017
  • 负责人:
    Elizabeth M McClure
  • 依托单位:
海外基金