Perinatal
Conditions
Keywords
propofol tenofovir, HBV DNA, mother-to-child block, New crown vaccination, Perinatal period
Brief summary
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
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.
Interventions
BIOLOGICALNew crown vaccine
New Coronavirus vaccine
Sponsors
Beijing Ditan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal congenital malformation rate | at birth | Observe whether the newborn has malformation |
| Intellectual development of 1-year-old children | at one year old | The intellectual development of newborns was observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of maternal adverse events during pregnancy | during pregnancy | Observe the incidence of maternal adverse events during pregnancy |
| Physical development of children at birth and 1 year old | at birth, at 1 year old | Observe the physical development of children at birth and 1 year old |
| The incidence of adverse events among children aged 1 year | among 1 year old | Observe the incidence of adverse events among children aged 1 year |
Countries
China
Contacts
Primary ContactWei Yi, Doctor
Backup ContactYao Xie, Doctor
Outcome results
None listed