跳至主要内容
临床试验/NCT03403543
NCT03403543Unknown不适用

Chinese Pregnant Woman Cohort Study

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,000
试验地点
1
主要终点
preterm birth

研究概览

简要总结

Purpose To determine the relationship between maternal lifestyle and obstetric and neonatal outcomes.

Methods and analysis This is a multicentre, prospective, cohort study including more than 5000 participants in 24 hospitals in 12 provinces from July 2017 to July 2018 in China. Maternal lifestyle (environmental exposures, diet, physical activity, sleeping, psychology and economics) and metabolic status will be collected by the electronic self-administered questionnaire at the first, second and third trimesters and 42 days postpartum, respectively. Obstetric and neonatal outcomes and metabolic status recorded by a clinical research coordinator. Descriptive statistics will be used to investigate the outcomes of maternal and newborn across China. Logistical regression and covariance analysis will be used to determine the relationship between maternal lifestyle and obstetric and neonatal outcomes. 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 at Department of Scientific Research, Peking Union Medical College Hospital, 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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

preterm birth

时间窗: 2017.10.1-2019.3.1

The doctors will record the delivery time

birth weight

时间窗: 2017.10.1-2019.3.1

The doctors will record the birth weight

birth defects

时间窗: 2017.10.1-2019.3.1

The doctors will record the birth defects

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liangkun Ma

Obstetrics and Gynecology

Peking Union Medical College Hospital

研究点 (1)

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