Clinical Trials in China / NCT06927622
Recruiting
Observational
Corona Virus Disease 2019 Cohort Study
NCT06927622 · tracked via the Priya Life Science China tracker
Condition(s) studied
COVID-19 PneumoniaCOVID-19 PandemicCOVID-19
Study summary
The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
Eligibility
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.
Primary outcome measure(s)
- Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST). — 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. - Pregnancy complications or comorbidities — 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. - Obtain neonatal outcomes. — 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. - Comprehensive results of COVID-19 infection during pregnancy — 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.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Jinan Maternity and Child Health Care Hospital | Jinan | China | Recruiting |
| Qianfoshan Hospital | Jinan | China | Recruiting |
| Qilu Hospital of Shandong University | Jinan | China | Recruiting |
| Shandong Provincial Maternity and Child Health Care Hospital | Jinan | China | Recruiting |
More Shandong University trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06927622 on ClinicalTrials.gov ↗ ← All trials in China