Corona Virus Disease 2019 Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COVID-19 Pneumonia, COVID-19 Pandemic, COVID-19. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development
Overview
The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
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.
Primary outcome measures
- 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]
- Pregnancy complications or comorbidities [Time frame: 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]
- 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]
Secondary outcome measures (2)
- Delivery method [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- The Second Hospital of Shandong University — Jinan
- Jinan Maternity and Child Health Care Hospital — Jinan
- Qianfoshan Hospital — Jinan
- Qilu Hospital of Shandong University — Jinan
- Shandong Provincial Maternity and Child Health Care Hospital — Jinan
Identifiers
NCT: NCT06927622 · LL202303018