Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Having tumor-related diseases
- Having severe mental disorders
AI-Screening
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Your Study Journey
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.
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
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
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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