Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).
研究概览
简要总结
The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Concomitant tumor related diseases;
- •Individuals with severe mental disorders.
结局指标
主要结局
Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Yinuo Song
Principal Investigator
Shandong University