Corona Virus Disease 2019 Cohort Study
Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development
1 other identifier
observational
1,000
1 country
5
Brief Summary
The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedApril 15, 2025
April 1, 2025
2.7 years
November 27, 2023
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).
GDS mainly diagnoses four abilities: motor ability, object ability, speech ability, and human ability,. Thus, the development quotient of four aspects can be obtained. If the development quotient is below 65-75, it indicates serious backwardness. The DST assessment includes five functional areas: gross motor, fine motor, language, adaptability, and social behavior, to obtain developmental quotient, which is used to measure the developmental behavior of children and evaluate their level of development. A score above 130 indicates excellent performance, and a score below 70 indicates intellectual development disorder.
From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months
Pregnancy complications or comorbidities
Obtain relevant information from medical records. Pregnancy complications refer to non pregnancy related diseases that occur before or during pregnancy, while pregnancy complications refer to any diseases that coexist with pregnancy.
Starting prenatal examination until discharge，the evaluation take up to 10 months
Obtain neonatal outcomes.
Obtain neonatal outcomes from neonatal records, including macrosomia, neonatal asphyxia, fetal distress, low birth weight infants, and deformed infants.
The evaluation period from birth to discharge is up to 1 week
Comprehensive results of COVID-19 infection during pregnancy
Through questionnaires, medical records and test sheets, The investigators can get whether the pregnant women have been infected with COVID-19 during pregnancy, the time of infection, pregnancy weeks, symptoms, etc.
Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 years
Secondary Outcomes (2)
Delivery method
The evaluation period from admission to delivery to discharge is up to 1 week
Estimation of bleeding volume
The evaluation period from admission to delivery to discharge is up to 1 week
Eligibility Criteria
The population of this study is pregnant women who undergo regular prenatal examinations in hospitals, establish a prenatal care manual, plan hospital delivery, have no comorbid tumor diseases, are mentally normal, and are aged ≥ 18 years old.
You may qualify if:
- Conduct regular prenatal examinations in the hospital and establish a pregnancy and childbirth health manual, planning for pregnant women who are hospitalized for delivery;
- Conduct regular physical examinations in the hospital and establish a children's health manual for infants.
- Age ≥ 18 years old
You may not qualify if:
- Concomitant tumor related diseases;
- Individuals with severe mental disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- Qilu Hospital of Shandong Universitycollaborator
- Jinan Maternity and Child Health Care Hospitalcollaborator
- Shandong Provincial Maternity and Child Health Care Hospitalcollaborator
- The Second Hospital of Shandong Universitycollaborator
- Qianfoshan Hospitalcollaborator
Study Sites (5)
The Second Hospital of Shandong University
Jinan, Shandong, 250000, China
Jinan Maternity and Child Health Care Hospital
Jinan, China
Qianfoshan Hospital
Jinan, China
Qilu Hospital of Shandong University
Jinan, China
Shandong Provincial Maternity and Child Health Care Hospital
Jinan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fanzhen Hong, Doctorate
The Second Hospital of Shandong University
- STUDY DIRECTOR
Xia Luo, Doctorate
Qilu Hospital of Shandong University
- STUDY DIRECTOR
Yueqin Xu, Doctorate
Qianfoshan Hospital
- STUDY DIRECTOR
Qiuhong Yang, Doctorate
Jinan Maternity and Child Health Care Hospital
- STUDY CHAIR
Jie Chen, Doctorate
Shandong University
- PRINCIPAL INVESTIGATOR
Yinuo Song, Master
Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2023
First Posted
April 15, 2025
Study Start
April 1, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
April 15, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The investigators will be provided within 1 Year after the release of the main research findings
- Access Criteria
- Access is only provided after submitting research proposals and obtaining approval from an independent review team, as well as after the data sharing agreement is in place.
The investigators will only allow users to use the data and supporting files based on a clear data sharing agreement, which enforces (a) their commitment to use the data only for research purposes and will not identify any individual study participants; (b) Promise to use appropriate technology to protect all research data; (c) Prohibit the redistribution of data to third parties and appropriately confirm data resources, as well as (d) commit to destroying and/or returning data after analysis is completed. Co investigators can access data collected as part of their purpose. The investigators involved in this project can only access the data through the chief investigator. The investigators will regularly monitor data to maintain security, safety, and productivity.