Understanding COVID-19 Infections in Pregnant Women and Their Babies in Uganda, Kenya, Malawi, the Gambia and Mozambique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,635
- 试验地点
- 5
- 主要终点
- To describe the seroepidemiology of SARS-CoV-2 infection among African pregnant women from 5 African countries across several waves of the COVID-19 pandemic in those countries.
研究概览
简要总结
Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda
Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries
Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood
Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population
详细描述
This study has been set up as part of the response to the international outbreak of the novel Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). The aim of the study is to answer important questions about the impact of the novel coronavirus on pregnant women and their infants. The investigators aim to describe the sero-epidemiology and burden of COVID-19 disease among pregnant women, as well as the impact on maternal and neonatal health, by collecting epidemiological data and by collecting samples during pregnancy, labour and delivery and in the neonatal period.
Data from this study will be pooled from 5 countries; Malawi, Uganda, Mozambique, the Gambia, and Kenya to provide robust and generalisable evidence from the different regions in sub-Saharan Africa. the investigators hope that with this information, they can contribute to the evidence base for recommendations, guidance and policy decisions for the clinical management and public health response to protect pregnant women and their infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any pregnant woman or emancipated minor at any gestation, up to and including day of delivery. Individual study sites may have their own specific inclusion/exclusion criteria which is not listed here.
- •Accepts to read or to be read to and sign or fingerprint the approved study consent form
排除标准
- 未提供
结局指标
主要结局
To describe the seroepidemiology of SARS-CoV-2 infection among African pregnant women from 5 African countries across several waves of the COVID-19 pandemic in those countries.
时间窗: through study completion, an average of 1 year
The proportion of individuals who show seropositivity for SARS-CoV-2 virus. If data is collected, sero-prevalence by different groups (e.g. geography, profession, residence) will be an important sub-analysis.
次要结局
- To define the impact of SARS-CoV-2 infection in pregnancy adjusted for key pregnancy and neonatal outcomes as defined by the Global Alignment of Immunization safety Assessment in pregnancy (GAIA) criteria(through study completion, an average of 1 year)
- Estimate the fraction of asymptomatic or pre-symptomatic/ subclinical infections in the population of pregnant women sampled.(through study completion, an average of 1 year)