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

Beijing Ditan Hospital100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Perinatal

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Neonatal congenital malformation rate

Observe whether the newborn has malformation

Time frame: at birth

Intellectual development of 1-year-old children

The intellectual development of newborns was observed

Time frame: at one year old

Secondary Outcomes

Incidence of maternal adverse events during pregnancy

Observe the incidence of maternal adverse events during pregnancy

Time frame: during pregnancy

Physical development of children at birth and 1 year old

Observe the physical development of children at birth and 1 year old

Time frame: 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

Time frame: among 1 year old