NCT05125770

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

November 8, 2021

Last Update Submit

November 8, 2021

Conditions

Perinatal

Keywords

propofol tenofovirHBV DNAmother-to-child blockNew crown vaccinationPerinatal period

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Incidence of maternal adverse events during pregnancy

    during pregnancy

  • 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

    among 1 year old

Study Arms (2)

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

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

Interventions

New crown vaccineBIOLOGICAL

New Coronavirus vaccine

new crown vaccination

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Both husband and wife or family have previously delivered congenital abnormal fetus;
  • Neither husband nor wife was willing to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Central Study Contacts

Wei Yi, Doctor

CONTACT

13683687062yiwei1215@163.com

Yao Xie, Doctor

CONTACT

13501093293xieyao00120184@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Obstetrics and Gynecology

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 18, 2021

Study Start

November 8, 2021

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

CN(1)