Study on the Safety of New Coronavirus Vaccination for Couples During the Peri-pregnancy Period on the Fetus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neonatal congenital malformation rate
研究概览
简要总结
All the pregnant women and newborns of both or one of the couples who gave birth in Ditan hospital were collected as the observation group, and the pregnant women and newborns of both husband and wife who gave birth in our hospital without new crown vaccine during pregnancy were collected as the control group. The incidence of adverse events during pregnancy of the two groups and the incidence of intrauterine development and congenital malformations of the two groups were observed to observe the physical and intellectual development of children in the two groups at the age of 1 year, and to explore the safety of perinatal neocrown vaccination.
详细描述
This study is a prospective observational cohort study. All the pregnant women and newborns of both or one of the couples who gave birth in Ditan hospital were collected as the observation group, and the pregnant women and newborns of both husband and wife who gave birth in our hospital without new crown vaccine during pregnancy were collected as the control group. The incidence of adverse events during pregnancy of the two groups and the incidence of intrauterine development and congenital malformations of the two groups were observed to observe the physical and intellectual development of children in the two groups at the age of 1 year, and to explore the safety of perinatal neocrown vaccination.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The pregnant women and newborns who were injected with the new crown vaccine during the perinatal period of both husband and wife or one of them were the observation group, and the pregnant women and newborns who were not vaccinated with the new crown vaccine during the perinatal period of both husband and wife were the control group. They were fully informed of the risk, voluntarily joined the study and signed the informed consent.
排除标准
- •Both husband and wife or family have previously delivered congenital abnormal fetus;
- •Neither husband nor wife was willing to participate in this study.
结局指标
主要结局
Neonatal congenital malformation rate
时间窗: at birth
Observe whether the newborn has malformation
Intellectual development of 1-year-old children
时间窗: at one year old
The intellectual development of newborns was observed
次要结局
- The incidence of adverse events among children aged 1 year(among 1 year old)
- Incidence of maternal adverse events during pregnancy(during pregnancy)
- Physical development of children at birth and 1 year old(at birth, at 1 year old)
研究者
Wei Yi
Director, Head of Obstetrics and Gynecology
Beijing Ditan Hospital