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NCT Number: NCT06927622

Corona Virus Disease 2019 Cohort Study

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

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Key information

Conditions

COVID-19 Pneumonia COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Second Hospital of Shandong University, Jinan, Shandong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Delivery method

    Time frame: The evaluation period from admission to delivery to discharge is up to 1 week

    Natural delivery, vaginal surgery, or curettage.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Chen, Doctorate

CONTACT

[email protected]

18615656606 ext. 86

Yinuo Song

CONTACT

[email protected]

17861203953 ext. 86

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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