Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,393
- 试验地点
- 1
- 主要终点
- To assess the potential effects of vaccines on the mother.
研究概览
简要总结
Establish a cohort of pregnant women exposed to a COVID19 vaccine, whether or not they have experienced an adverse event, to assess the potential effects of vaccines on the course of pregnancy, on the fetus or newborn and on the mother.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient aged 18 years and over,
- •Pregnant,
- •Vaccinated against COVID-19,
- •Not having expressed any objection to inclusion in the cohort
排除标准
- •No agreement at inclusion,
- •Age under 18 years
结局指标
主要结局
To assess the potential effects of vaccines on the mother.
时间窗: One month after injection
Rates and types of adverse events following vaccination in pregnant women vaccinated against COVID 19
To assess the potential effects of vaccines on the fetus or newborn
时间窗: One month after injection
Characteristics of newborns (weight, height etc.) Malformation rate
To assess the potential effects of vaccines on the course of pregnancy.
时间窗: One month after injection
Pregnancy outcomes including the rate of spontaneous miscarriage, fetal death in utero, stillbirth
次要结局
未报告次要终点