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广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院)出生队列研究
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注册号:

Registration number:

ChiCTR1900024099 

最近更新日期:

Date of Last Refreshed on:

2019-06-25 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院)出生队列研究 

Public title:

Birth Cohort Study of Shunde Women and Children Hospital of Guangdong Medical University 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院)出生队列研究 

Scientific title:

Birth Cohort Study of Shunde Women and Children Hospital of Guangdong Medical University 

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:

曾娜 

研究负责人:

张金凤 

Applicant:

Zeng Na 

Study leader:

Zhang Jinfeng 

申请注册联系人电话:

Applicant telephone:

+86 18688267709 

研究负责人电话:

Study leader's telephone:

+86 18988665487 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

zengna103@126.com 

研究负责人电子邮件:

Study leader's E-mail:

406255627@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.sdfybj.com/ 

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:

广东省佛山市顺德区大良保健路3号 

研究负责人通讯地址:

广东省佛山市顺德区大良保健路3号 

Applicant address:

3 Baojian Road, Daliang, Shunde District, Foshan, Guangdong, China 

Study leader's address:

3 Baojian Road, Daliang, Shunde District, Foshan, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

528300 

研究负责人邮政编码:

Study leader's postcode:

528300 

申请人所在单位:

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院) 

Applicant's institution:

Shunde Women and Children hospital of Guangdong 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:

2019034 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院)医学研究伦理审查委员会 

Name of the ethic committee:

Medical Research Ethics Committee, Shunde Women and Children Hospital of Guangdong Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-03 

伦理委员会联系人:

李明明 

Contact Name of the ethic committee:

Li Mingming 

伦理委员会联系地址:

广东省佛山市顺德区大良保健路3号 

Contact Address of the ethic committee:

3 Baojian Road, Daliang, Shunde District, Foshan, Guangdong, China 

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:

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院) 

Primary sponsor:

Shunde Women and Children hospital of Guangdong Medical University 

研究实施负责(组长)单位地址:

广东省佛山市顺德区大良保健路3号 

Primary sponsor's address:

3 Baojian Road, Daliang, Shunde District, Foshan, Guangdong, 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):

广东省

市(区县):

佛山市顺德区

Country:

China

Province:

Guangdong

City:

Foshan, Shunde

单位(医院):

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院)

具体地址:

大良保健路3号

Institution
hospital:

Shunde Women and Children hospital of Guangdong Medical University

Address:

3 Baojian Road, Daliang, Shunde District, Foshan, Guangdong, China

经费或物资来源:

政府资助、单位自筹、项目经费等 

Source(s) of funding:

Government subsidies, self-funding units, project funds, etc 

研究疾病:

孕期健康, 婴幼儿发育 

Target disease:

Pregnancy women health, fetal and child development 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

以孕期社会学特征、环境接触、营养状况、饮食习惯、生活方式、睡眠状况、心理状态、活动状态等为暴露因素,以孕期健康状况、妊娠结局、婴幼儿及儿童生长发育及心理行为等为随访结局,通过问卷调查和样本采集两种方式对暴露因素和随访结局进行评估,评估社会因素、环境暴露、遗传特征等对胎儿与儿童生长发育、疾病发生等的影响。 

Objectives of Study:

Risk factors include social characterisitcs in pregnancy, environmental exposure, nutrition, diet, lifestyle, sleep state, psychological state, active state. Methods include questionnaire investigation and sample collection. Outcomes include pregnancy healthy status, pregnancy outcomes, infant and children's health growth and psychological behavior.Aimed at assess the social factors, environmental exposure, genetic characteristics on the influence of children's growth and development of diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

①纳入时孕周不超过20周;②佛山市户籍或在顺德区居住超过半年且相对稳定;③计划在我院产检和分娩;④同意参加SDBC。 

Inclusion criteria

1. less than 20 weeks of gestationla; 2. Foahan location of lived in Shuhde more than half year; 3. Plan to delivery in our hospital; 4. Agree to participate in SDBC. 

排除标准:

①患有严重精神疾病、智力障碍;②对问卷难以理解无法完成;③有严重的妊娠合并症或并发症;④拒绝参加者。 

Exclusion criteria:

1. Severe mental inllness, mental retardation; 2. Cannot be undersatand the questionnaire completed; 3. Severe pregnancy complications; 4. Refuse to be involved in the investigation. 

研究实施时间:

Study execute time:

From2020-01-01To 2030-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

5000

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

佛山市顺德区 

Country:

China 

Province:

Guangdong 

City:

Foshan, Shunde 

单位(医院):

广东医科大学顺德妇女儿童医院(佛山市顺德区妇幼保健院) 

单位级别:

三级甲等 

Institution
hospital:

Shunde Women and Children hospital of Guangdong Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

调查问卷

指标类型:

主要指标 

Outcome:

questionnaire

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:

标本中文名:

血液

组织:

静脉

Sample Name:

blood

Tissue:

vein

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50 years

标本中文名:

脐带血

组织:

断脐后胎盘端脐带

Sample Name:

umbilical cord blood

Tissue:

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50 years

标本中文名:

脐带

组织:

断脐后太判断脐带

Sample Name:

umbilical cord

Tissue:

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50 years

标本中文名:

胎盘

组织:

分娩后胎盘

Sample Name:

placenta

Tissue:

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50 years

标本中文名:

粪便

组织:

肠道排泄物

Sample Name:

stool

Tissue:

Intestinal

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50year

标本中文名:

尿液

组织:

肾脏排泄物

Sample Name:

urine

Tissue:

Kidney

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50year

标本中文名:

头发

组织:

头发

Sample Name:

hair

Tissue:

hair

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50year

标本中文名:

指甲

组织:

指甲

Sample Name:

nail

Tissue:

nail

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50year

标本中文名:

指甲

组织:

指甲

Sample Name:

nail

Tissue:

nail

人体标本去向

使用后保存 

说明

50年

Fate of sample:

Preservation after use 

Note:

50year

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 18 years
最大 Max age 50 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究为出生队列研究,为前瞻性观察研究,无相关产生随机序列方法

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

N/A

盲法:

N/A

Blinding:

N/A

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):

暂无

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

No

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:

数据采集使用CRF表,通过本研究数据安全与监察委员会管理。

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-25
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