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

Perinatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125770
• Other study ID #: KY2021-12
• Status: Recruiting
• Start date: November 8, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2021
• Source: Beijing Ditan Hospital
• Contact: Wei Yi, Doctor
• Phone: 13683687062
• Email: yiwei1215[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• Perinatal

Intervention

Biological:
• New crown vaccine
New Coronavirus vaccine

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal congenital malformation rate	Observe whether the newborn has malformation	at birth
Primary	Intellectual development of 1-year-old children	The intellectual development of newborns was observed	at one year old
Secondary	Incidence of maternal adverse events during pregnancy	Observe the incidence of maternal adverse events during pregnancy	during pregnancy
Secondary	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
Secondary	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