Clinical trial NCT05125770: Study on the Fetal Safety of New Coronavirus Vaccination for Couples During the Peri-pregnancy Period
Official title: Study on the Safety of New Coronavirus Vaccination for Couples During the Peri-pregnancy Period on the Fetus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perinatal
Keywords: propofol tenofovir
HBV DNA
mother-to-child block
New crown vaccination
Perinatal period
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neonatal congenital malformation rate
timeFrame: at birth
measure: Intellectual development of 1-year-old children
timeFrame: at one year old
Secondary outcomes:
measure: Incidence of maternal adverse events during pregnancy
timeFrame: during pregnancy
measure: Physical development of children at birth and 1 year old
timeFrame: at birth, at 1 year old
measure: The incidence of adverse events among children aged 1 year
timeFrame: among 1 year old
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
Study officials:
References: