Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,362
- 试验地点
- 1
- 主要终点
- Outcome of pregnancy
研究概览
简要总结
This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.
详细描述
All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother.
In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured.
Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For pregnant women, all women who deliver in the CHU St Pierre, with oral consent.
- •For children follow up: children born to positive mothers and matched controls after written consent
排除标准
- 未提供
结局指标
主要结局
Outcome of pregnancy
时间窗: Up to the delivery
Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
次要结局
- Prevalence of positive serology to SARS-CoV-2 at delivery(At the delivery)
- Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers(At 1 month post delivery)
- To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life(Up to 1 month post delivery)
- Clinical evolution of the children(Up to 3 years)
- To characterize placental alterations related to SARS-CoV-2 infection(At the delivery)
- Transplacental transfer of antibodies to SARS-CoV-2(At the delivery)