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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new crown vaccination | Collect all the couples who gave birth in Ditan Hospital or one of the mothers and newborns who were injected with the new crown vaccine during the peri-pregnancy period as the observation group |
| |
| non new crown vaccination | Collect the pregnant women and newborns who were not vaccinated with the new crown vaccine during the peri-pregnancy of the couples who gave birth in our hospital during the same period as the control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New crown vaccine | Biological | New Coronavirus vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal congenital malformation rate | Observe whether the newborn has malformation | at birth |
| Intellectual development of 1-year-old children | The intellectual development of newborns was observed | at one year old |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of maternal adverse events during pregnancy | Observe the incidence of maternal adverse events during pregnancy | during pregnancy |
| Physical development of children at birth and 1 year old |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Yi, Doctor | Contact | 13683687062 | yiwei1215@163.com | |
| Yao Xie, Doctor | Contact | 13501093293 | xieyao00120184@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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Observe the physical development of children at birth and 1 year old
| at birth, at 1 year old |
| The incidence of adverse events among children aged 1 year | Observe the incidence of adverse events among children aged 1 year | among 1 year old |