Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID06927622

Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development

Led by Shandong University · Updated on 2025-04-15

1000

Participants Needed

5

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Shandong University

Lead Sponsor

Q

Qilu Hospital of Shandong University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how Coronavirus Disease 2019 (COVID-19) affects pregnancy outcomes and the development of children born to infected mothers. It compares pregnant women who had COVID-19 with those who did not, analyzing potential adverse effects on both mothers and their offspring. The study is observational and sponsored by Shandong University. Participants are grouped based on whether they had COVID-19 during pregnancy. Researchers collect detailed information on infection status, medications used, and pregnancy details. The study follows the children born in this cohort to assess their nervous system development over time. During the study, participants undergo regular prenatal exams and newborn health checks. Researchers assess pregnancy complications, birth outcomes, and child development using tools like the Gesell Development Scale or the 0-6-year-old Child Development Scale. Outcomes are monitored from pregnancy through at least the first year after birth, with evaluations continuing up to six months for child development and up to one year for COVID-19 infection effects.

CONDITIONS

Brief Title

Corona Virus Disease 2019 Cohort Study

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women receiving regular prenatal exams in a hospital and planning to deliver in a hospital
  • Infants receiving regular physical exams in a hospital with a children's health manual established
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Having tumor-related diseases
  • Having severe mental disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants receive regular prenatal or physical exams as part of routine care.

Monitoring

Duration - From prenatal examination until delivery and discharge, up to 10 months

Participants who undergo routine prenatal and neonatal care are observed to collect data about pregnancy complications, birth outcomes, and COVID-19 infection effects.

Visits coincide with regular prenatal and delivery care visits

Long-term Monitoring

Duration - From 6 months after birth to completion of developmental assessments, up to 6 months

Offspring are followed up to assess nervous system development up to 6 months using standardized developmental scales.

Regular developmental assessment visits over up to 6 months

Trial Site Locations

Total: 5 locations

1

The Second Hospital of Shandong University

Jinan, Shandong, China, 250000

Actively Recruiting

2

Jinan Maternity and Child Health Care Hospital

Jinan, China

Actively Recruiting

3

Qianfoshan Hospital

Jinan, China

Actively Recruiting

4

Qilu Hospital of Shandong University

Jinan, China

Actively Recruiting

5

Shandong Provincial Maternity and Child Health Care Hospital

Jinan, China

Actively Recruiting

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Research Team

J

Jie Chen, Doctorate

Y

Yinuo Song

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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