NCT04703270已完成不适用
Understanding COVID-19 Infection in Pregnant Women and Their Babies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 881
- 试验地点
- 1
- 主要终点
- Antibody Concentrations in Maternal Blood in Pregnant Women in England
研究概览
简要总结
This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Signed informed consent form
- •Any woman pregnant in selected hospitals in England who has no signs or symptoms of COVID-19 disease during pregnancy and is rtPCR negative at delivery
- •Any woman pregnant in any hospital in England who tests positive by rtPCR at any point during pregnancy from 24 weeks gestation onwards, regardless of signs and symptoms
排除标准
- •If the pregnant woman is under 18 years in prison or unable to make an informed consent for other reasons (e.g. learning difficulties, language barriers)
结局指标
主要结局
Antibody Concentrations in Maternal Blood in Pregnant Women in England
时间窗: Delivery
Antibody concentrations in maternal blood in pregnant women in England: ADCD-S values reported
Antibody Concentrations in Cord/Infant Blood at Delivery
时间窗: Delivery
Cord blood was tested to determine infant antibody levels; where a cord blood sample was not available, a blood sample was taken from the infant instead. ADCD-S assay results are presented.
次要结局
- Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2(At birth)
- Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery(Delivery)
- Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery(Delivery)
- Breastmilk Samples That Are rtPCR Positive(Delivery)
- Placental Samples That Are rtPCR Positive(Delivery)
- Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro(Delivery)
- Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro(Delivery)
- Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro(6 weeks post delivery)
研究者
研究点 (1)
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