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

NCT ID: NCT05125770

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-08

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Perinatal

Keywords

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propofol tenofovir HBV DNA mother-to-child block New crown vaccination Perinatal period

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

New crown vaccine

Intervention Type BIOLOGICAL

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

No interventions assigned to this group

Interventions

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New crown vaccine

New Coronavirus vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Yi

Director, Head of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Yi, Doctor

Role: CONTACT

Phone: 13683687062

Email: [email protected]

Yao Xie, Doctor

Role: CONTACT

Phone: 13501093293

Email: [email protected]

Facility Contacts

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Wei Yi

Role: primary

Yao Xie

Role: backup

Other Identifiers

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KY2021-12

Identifier Type: -

Identifier Source: org_study_id