Corona Virus Disease 2019 Cohort Study

April 14, 2025 updated by: Yinuo Song, Shandong University

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

The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The main questions it aims to answer are:

  • Collect the information about Corona Virus Disease 2019 infection and medication of pregnant women to establish a birth cohort, and analyze the correlation between Corona Virus Disease 2019 infection during pregnancy and adverse pregnancy outcomes and birth outcomes.
  • The offspring born in this cohort were followed up to analyze the effects of Corona Virus Disease 2019 infection during pregnancy on the nervous system development of the offspring.

Researchers will compare Corona Virus Disease 2019 infection group and uninfected group during pregnancy to see if Corona Virus Disease 2019 infection has adverse effects on pregnant women and their offspring.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • JiNan, China
        • Recruiting
        • Jinan Maternity and Child Health Care Hospital
        • Contact:
      • JiNan, China
        • Recruiting
        • Qianfoshan Hospital
        • Contact:
      • JiNan, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • JiNan, China
        • Recruiting
        • Shandong Provincial Maternity and Child Health Care Hospital
        • Contact:
    • Shandong
      • JiNan, Shandong, China, 250000
        • Recruiting
        • The Second Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Concomitant tumor related diseases;
  • Individuals with severe mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).
Time Frame: From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months
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
Time Frame: Starting prenatal examination until discharge，the evaluation take up to 10 months
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.
Time Frame: The evaluation period from birth to discharge is up to 1 week
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
Time Frame: Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery method
Time Frame: The evaluation period from admission to delivery to discharge is up to 1 week
Natural delivery, vaginal surgery, or curettage.
The evaluation period from admission to delivery to discharge is up to 1 week
Estimation of bleeding volume
Time Frame: The evaluation period from admission to delivery to discharge is up to 1 week
Total amount of bleeding during or 24 hours postpartum.
The evaluation period from admission to delivery to discharge is up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Qilu Hospital of Shandong University
Qianfoshan Hospital
The Second Hospital of Shandong University
Jinan Maternity and Child Health Care Hospital
Shandong Provincial Maternity and Child Health Care Hospital

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LL202303018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The investigators will be provided within 1 Year after the release of the main research findings

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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