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大气污染物生命早期暴露的出生队列研究
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注册号:

Registration number:

ChiCTR-ROC-16010181 

最近更新日期:

Date of Last Refreshed on:

2016-12-18 

注册时间:

Date of Registration:

2016-12-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

大气污染物生命早期暴露的出生队列研究 

Public title:

Birth Cohort Study of Early Life Exposure to Air Pollutants 

注册题目简写:

出生队列研究 

English Acronym:

Birth Cohort Study 

研究课题的正式科学名称:

北京大气污染对心肺疾病影响的暴露科学、毒理基因组学和环境流行病学综合研究之大气污染物生命早期暴露的出生队列研究 

Scientific title:

Integrated Research of Exposure Science, Toxicogenomics and Environmental Epidemiology of Air Pollution Impact on Cardiopulmonary Disease in Beijing Birth Cohort Study of Early Life Exposure to Air Pollutants 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

陈奕 

研究负责人:

陈奕 

Applicant:

CHEN YI 

Study leader:

CHEN YI 

申请注册联系人电话:

Applicant telephone:

+86 13601354010 

研究负责人电话:

Study leader's telephone:

+86 13601354010 

申请注册联系人传真 :

Applicant Fax:

8610 85968407 

研究负责人传真:

Study leader's fax:

8610 85968407 

申请注册联系人电子邮件:

Applicant E-mail:

bjfcyycy@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

bjfcyycy@sina.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市朝阳区姚家园路251号北京妇产医院七病区 

研究负责人通讯地址:

北京市朝阳区姚家园路251号北京妇产医院七病区 

Applicant address:

7th Ward, 251 Yaojiayuan Road, Chao Yang District, Beijing, China 

Study leader's address:

7th Ward, 251 Yaojiayuan Road, Chao Yang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100026 

研究负责人邮政编码:

Study leader's postcode:

100026 

申请人所在单位:

首都医科大学附属北京妇产医院 

Applicant's institution:

Beijing Obstetrics & Gynecology Hospital, Capital Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2016-KY-059-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

首都医科大学附属北京妇产医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-09-19 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

首都医科大学公共卫生学院 

Primary sponsor:

The capital medical university school of public health 

研究实施负责(组长)单位地址:

北京市右安门外西头条10号 

Primary sponsor's address:

10 West Toutiao Street, Outside You an Men, Feng Tai District, Beijing China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京妇产医院

具体地址:

北京市朝阳区姚家园路251号

Institution
hospital:

Beijing Obstetrics & Gynecology Hospital, Capital Medical University

Address:

251 Yaojiayuan Road, Chao Yang District, Beijing, China

经费或物资来源:

中国国家自然科学基金委 

Source(s) of funding:

China national natural science foundation 

研究疾病:

不良妊娠结局 

Target disease:

adverse pregnancy outcome 

研究疾病代码:

 

Target disease code:

 

研究类型:

相关因素研究 

Study type:

Relative factors research 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

本研究的目的在于建立孕产妇及出生人口队列,基于出生队列建立孕产妇及新生儿信息数据库及生物学样本库,进行生命早期环境暴露因素与不良妊娠结局、出生缺陷及新生儿呼吸系统、心血管系统疾病的相关性研究,探讨孕期不同时期PM2.5、PM10、SO2、NO等不同暴露与早产、胎儿生长受限、低出生体重、死胎、死产等不良结局的关系,与新生儿先天性心脏病、神经管畸形、唇腭裂、生殖系统畸形等出生缺陷的相关性。并进一步进行生命早期暴露导致不良出生结局的机制研究探索,以尽可能减少和避免高危因素、减少和预防因环境因素所致出生缺陷及不良妊娠结局的发生,减少婴幼儿呼吸及心血管系统疾病发生率,改善母儿不良结局,提高人口素质。 

Objectives of Study:

The objectives of this study are to establish a maternal and birth cohort, then set up a maternal and newborn information database and biological sample library based on the cohort; to study the correlations between early life environmental exposures and adverse pregnancy outcomes, birth defects, and neonatal respiratory system and cardiovascular system diseases; and to investigate the correlations between different exposures to PM2.5, PM10, SO2, and NO at different pregnancy stages and adverse pregnancy outcomes including preterm birth, fetal growth restriction, low birth weight, and stillbirth, as well as the correlations to birth defects like congenital heart disease, neural tube defects, cleft lip and palate, and reproductive abnormalities. This study also aims to further investigate the mechanisms underlying the impact of early life exposures to adverse birth outcomes, so as to reduce and avoid high-risk factors, decrease the occurrence of birth defects and adverse pregnancy outcomes due to environmental factors, reduce infant respiratory and cardiovascular diseases, improve mother and child adverse outcomes and improve population quality. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

自2017年1月1日-2018年12月31日选取在首都医科大学附属北京妇产医院建档产检的产妇,在本院分娩并能在本市居住三年、自愿参与本研究并签订知情同意书的单胎孕妇2000例,并同意其娩出的新生儿进入出生队列研究,并能在我院儿童保健门诊进行定期随访至1岁。 

Inclusion criteria

A total of 2000 singleton pregnant women will be recruited from June, 2017 to Dec, 2018 during their routine antenatal check at Beijing Obstetrics and Gynecology Hospital of Capital Medical University; they will be delivering in our hospital and are planning to reside in Beijing for at least 3 years. Women who are to recruited will be those who will show interest in the study and agree to provide informed written consent, and 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 1 year.  

排除标准:

早孕期有放射性物质接触史、服用致畸药物史、早孕期高热(高于38.5℃)、家族遗传性疾病史、近亲婚配、孕妇本人或丈夫染色体异常等 

Exclusion criteria:

Pregnant women with a history of radioactive material contact, a history of using teratogenic drugs, or having a fever during early pregnancy (body temperature >38.5 degree C) will be excluded. 

研究实施时间:

Study execute time:

From2017-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

2000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京妇产医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Obstetrics & Gynecology Hospital,Capital Medical University  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

早产、胎儿生长受限、低出生体重、死胎、死产等不良结局的关系,与新生儿先天性心脏病、神经管畸形、唇腭裂、生殖系统畸形等出生缺陷

指标类型:

主要指标 

Outcome:

The relationship between premature delivery, fetal growth restriction, low birth weight and adverse outcomes such as fetal death and stillbirth, neonatal with congenital heart disease, neural tube malformation, cleft palate, reproductive system abnormalities and birth defects

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

队列研究不进行研究对象的随机分组。

Randomization Procedure (please state who generates the random number sequence and by what method):

Cohort studies did not carry out random grouping of subjects

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2020年6月, 首都医科大学附属北京妇产医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

June 2020, Beijing Obstetrics and Gynecology Hospital, Capital Medical University

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

北京妇产医院生命早期暴露出生队列数据库

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Birth Cohort metadata of Beijing Obstetrics & Gynecology Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-12-18
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