Coxsackievirus Group B (CVB) Infection in Early Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Maternal prenatal and newborn Cox B antibody levels
研究概览
简要总结
Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)
详细描述
The investigator proposes that Coxsackievirus group B (CVB) infection in early pregnancy induces pathological changes in congenital heart defects. To test the hypothesis, it will be determined if the incidence of CVB infection in women with babies that are congenital heart defect-(CHD) affected pregnancies are higher than in control subjects.
After informed consent participants will provide the following samples during one study visit: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire Our 3 study groups are the following-Group 1 is Hypoplastic Left Heart Syndrome or HLHS effected pregnancies. Group 2 is OCHD- Other Congenital Heart Defects and Group 3 is Unaffected Controls (UC) also known as healthy controls.
After informed consent participants will provide the following samples: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab).
A health history review and questionnaire will also be obtained.
Analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maternal prenatal and newborn Cox B antibody levels
时间窗: 3 - 5years
Serum CVB antibody titers: Past or current CVB infection will be determined from titers (\>/= 1:80) collected from stool, serum and a nasal swab.
Maternal prenatal and newborn Cox B viral strand identification
时间窗: 3 - 5years
Virus identification: Comparison to VP1 sequences available in GenBank will be used to identify the strain of CVB in the isolates.
次要结局
- Variables and trends influencing Congenital Heart Disease(3-5 years)