Study on the Fetal Safety of New Coronavirus Vaccination for Couples During the Peri-pregnancy Period

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on the Safety of New Coronavirus Vaccination for Couples During the Peri-pregnancy Period on the Fetus

Conditions
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Perinatal

Intervention / Treatment
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* Biological: New crown vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Both husband and wife or family have previously delivered congenital abnormal fetus; Neither husband nor wife was willing to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| new crown vaccination<br>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 | Biological: New crown vaccine<br>* New Coronavirus vaccine<br>|
| non new crown vaccination<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol tenofovir, HBV DNA, mother-to-child block, New crown vaccination, Perinatal period