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临床试验/NCT03830879
NCT03830879招募中不适用

Shenzhen Birth Cohort Study

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2018年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Fetal outcomes.

研究概览

简要总结

The Shenzhen Birth Cohort Study was set up to investigate the effect of early life environmental exposures on short- and long-term health consequences in Shenzhen, China.

详细描述

Shenzhen Birth Cohort (Xinmiao Project) is a scientific research/public health project under the support of Shenzhen city and Nanshan district, which was jointly initiated by Nanshan Maternity and Child Healthcare Hospital of Shenzhen and school of public health, Sun Yat-sen University. The project plans to recruit 10,000 participants in early pregnancy and follow up for seven years in the first stage. Biological samples, questionnaires and data for child growth and development, disease and health will be collected. The study is aimed to provide evidence for DOHaD Hypothesis and find the prevention and control measures for some childhood diseases. The core members of the research team are composed of experts from different disciplines in the field of public health, including 4 professors and 3 associate professors. With the support of an executive sponsor, the project is undertaken by the Birth Cohort Study Center. Currently, the center has 3 staff form hospital (one doctor and two masters ) and 5-7 master candidates from Sun Yat-sen University. It is an energetic and enthusiastic team.

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
15 Years 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women plan to delivery and participate in child care in our hospital;
  • Pregnant women plan to reside in Shenzhen for at least 7 years;
  • Pregnant women who show interest in the study and agree to provide informed consent;
  • Gestational weeks are less than 20 weeks.Those who will agree that their neonatal will be included in the study and be followed up regularly in our child health clinic until an age of 7 years.

排除标准

  • Pregnant women who have been pregnant for more than 20 weeks; refuse to participate; unable to guarantee delivery in our hospital or can't participate in child care in our hospital; mentally incapacitated and need guardians; or be unwilling to sign informed consent.

结局指标

主要结局

Fetal outcomes.

时间窗: At delivery.

Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.

次要结局

  • Number of participant with postnatal depression.(At 30 days after delivery, 3 months, 6 months after delivery.)
  • Number of participant with gestational complications.(At delivery.)
  • Neurodevelopment.(at age of 1 month, 3 months, 6months, 1 year, 3 years and 5 years.)
  • Physical development.(at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years.)
  • Maternal weight changes (kg).(At pre-pregnancy period, 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Cai

Associate professor

Sun Yat-sen University

研究点 (1)

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