Chinese Pregnant Woman Cohort Study (Offspring Follow-up)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,978
- 试验地点
- 1
- 主要终点
- Infants' oral development
研究概览
简要总结
Purpose: To investigate the growth and development status for children of 1 ~ 3 years old in China, and to explore and analyze the influencing factors of infant growth. Mother's health status would also be investigated simultaneously.
Methods and analysis: This is a multicenter prospective cohort study. Participants were all from the Chinese Pregnant Women Cohort Study (CPWCS), which is a multicenter prospective cohort study we conducted before. In simple terms, pregnant women during the first trimester (5~13 weeks' gestational age) were included from 25 July 2017 to 26 November 2018. Related information were collected by electronic self-administered questionnaire, including general information, environmental exposure assessment, physical activity assessment, dietary and nutritional assessment, depression assessment, sleep quality assessment and economic burden assessment. Subsequently, objective medical information, obstetric and neonatal outcomes were collected through hospital information system (HIS).
To further assess the mothers' and infants' health status, a new multicenter prospective cohort study, including more than 1000 participants of the CPWCS from 5 hospitals of 5 different provinces in China, will be conducted. Through the electronic self-administered questionnaire surveys and laboratory testing methods, information about infants' feeding, sleeping, defecating, oral health, early development and common allergic diseases will be collected. And we will also assess mothers' current health habits and status, such as sleeping, diet, anxiety, physical activity, and oral health. SAS statistical software will be used for data analysis.
Ethics and Dissemination Permission for the study was obtained from Chinese Academy of Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the Ethics Review Committee of Department of Scientific Research, School of Basic Medicine, Peking Union Medical College, Beijing, China. The results will be published in peer-reviewed journals or disseminated through conference presentations.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •participated in the CPWCS and were pregnant women included in the previous cohort;
- •the baseline, first trimester, delivery outcomes, and neonatal outcomes data in the CPWCS were complete;
- •live birth and singleton in the CPWCS;
- •participate in the CPWCS-OF with child born in the CPWCS willingly;
- •able to complete the questionnaire;
- •resident in the study area;
- •signed the informed consent.
排除标准
- •subjects not included in the CPWCS;
- •incomplete data in either of baseline, first trimester, delivery outcomes, and neonatal outcomes in the CPWCS;
- •pregnancy outcomes in the CPWCS were not singleton (abortion, stillbirth, twins, multiple births);
- •no longer resident in the study area;
- •the child has died;
- •the mother currently has mental problems and cannot cooperate well with the research.
结局指标
主要结局
Infants' oral development
时间窗: 2020.8.1-2020.12.1
Infants' early development
时间窗: 2020.8.1-2020.12.1
Infants' and young children's feeding situation
时间窗: 2020.8.1-2020.12.1
The mother will report these questions.
Infants' sleeping conditions
时间窗: 2020.8.1-2020.12.1
Infants' defecation situation
时间窗: 2020.8.1-2020.12.1
Mother' knowledge of infant oral health care
时间窗: 2020.8.1-2020.12.1
Infants' physical health (asthma, allergies, autism)
时间窗: 2020.8.1-2020.12.1
次要结局
- Mothers' lifestyle (smoking, sleeping)(2020.8.1-2020.12.1)
- Mothers' anxiety condition(2020.8.1-2020.12.1)
- Mothers' physical activity(2020.8.1-2020.12.1)
- Mothers' dietary patterns(2020.8.1-2020.12.1)
- Mothers' oral health(2020.8.1-2020.12.1)
研究者
Yu Jiang
School of Public Health
Peking Union Medical College