A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Neonates in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,855
- 试验地点
- 2
- 主要终点
- Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
研究概览
简要总结
The purpose of this study is to assess the risk of congenital cytomegalovirus (cCMV) infection in newborns born to seropositive women.
详细描述
This study will be conducted at several Maternal and Child Health Hospitals (MCHHs) in China and the research activities will be integrated with routine medical services during pregnancy at the study sites.The investigators will build a perspective cohort study enrolling ~8000 pregnant women elder than 18 and following up their newborns at specific MCHHs.As a first step, The investigators will work with these hospitals to recruit the subjects. After being informed, the participants' remaining blood and urine samples (after their medical examinations) at their early, medium and late stages of pregnancy will be collected , and their newborns' urine and saliva samples will be collected after delivery. The aim of this study is to enroll 5000 series mother-newborns.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18 and older
- •Pregnancy confirmed by ultrasound
- •Come to MCHHs for "Pregnancy Registry" within 24 weeks of pregnancy
排除标准
- •Not capable of complying with study procedures, or having a psychosis, two-stage affective psychosis, or have a tendency to suicide
- •Having any autoimmune diseases (include systemic lupus erythematosus, rheumatoid arthritis), immunodeficiency (e.g. AIDS), chronic disease history such as cancers
结局指标
主要结局
Incidence of cCMV infection in newborns born to CMV seropositive pregnant women.
时间窗: up to 45 months
次要结局
- Incidence of cCMV infection in newborns to pregnant women with different maternal PP150-IgG titers in the early pregnancy.(up to 45 months)
研究者
Jun Zhang
Vice dean of School of Public Health,Xiamen University
Xiamen University