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

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 Overview

• Status: Recruiting
• Conditions: Perinatal
• Intervention / Treatment: Biological: New crown vaccine

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Recruiting
      • Beijing Ditan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
new crown vaccination; Collect all the couples who gave birth in Ditan Hospital or one of the mothers and newborns who were injected with the new crown vaccine during the peri-pregnancy period as the observation group	Biological: New crown vaccine; New Coronavirus vaccine
non new crown vaccination; Collect the pregnant women and newborns who were not vaccinated with the new crown vaccine during the peri-pregnancy of the couples who gave birth in our hospital during the same period as the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal congenital malformation rate	Observe whether the newborn has malformation	at birth
Intellectual development of 1-year-old children	The intellectual development of newborns was observed	at one year old

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of maternal adverse events during pregnancy	Observe the incidence of maternal adverse events during pregnancy	during pregnancy
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
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

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: HBV DNA; propofol tenofovir; mother-to-child block; New crown vaccination; Perinatal period
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: KY2021-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No