NCT05125770

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perinatal

Interventions

Type	Name	Description
BIOLOGICAL	New crown vaccine	New Coronavirus vaccine

Timeline

• Start date: 2021-11-08
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: China