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Effects of Intrauterine Exposure of Environmental Estrogen Disruptors on Growth and Development of Infants and Children
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注册号:

Registration number:

ChiCTR1900026149 

最近更新日期:

Date of Last Refreshed on:

2019-09-24 

注册时间:

Date of Registration:

2019-09-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

环境雌激素干扰物宫内暴露对婴幼儿生长发育的影响 

Public title:

Effects of Intrauterine Exposure of Environmental Estrogen Disruptors on Growth and Development of Infants and Children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

环境雌激素干扰物宫内暴露对婴幼儿生长发育的影响 

Scientific title:

Effects of Intrauterine Exposure of Environmental Estrogen Disruptors on Growth and Development of Infants and Children 

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:

卢莎 

研究负责人:

胡文胜 

Applicant:

LU SHA 

Study leader:

HU WENSHENG 

申请注册联系人电话:

Applicant telephone:

+86 13777829574 

研究负责人电话:

Study leader's telephone:

+86 13857147977 

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:

lushaziyu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huws@zju.edu.cn 

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:

杭州市上城区鲲鹏路369号杭州市妇产科医院门诊5楼产前诊断中心医生办公室 

研究负责人通讯地址:

杭州市上城区鲲鹏路369号杭州市妇产科医院门诊5楼产前诊断中心医生办公室 

Applicant address:

369 Kunpeng Road, Hangzhou, Zhejiang, China 

Study leader's address:

369 Kunpeng Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

杭州市妇产科医院 

Applicant's institution:

Hangzhou Women's Hospital 

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:

【2018】医伦审第(009)号-01 

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:

杭州市妇产科医院伦理委员会 

Name of the ethic committee:

The ethics committee of Hangzhou Women's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-15 

伦理委员会联系人:

黄坚 

Contact Name of the ethic committee:

HUANG JIAN 

伦理委员会联系地址:

杭州市上城区鲲鹏路369号杭州市妇产科医院 

Contact Address of the ethic committee:

369 Kunpeng Road, Hangzhou, Zhejiang, 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:

杭州市妇产科医院 

Primary sponsor:

Hangzhou Women's Hospital 

研究实施负责(组长)单位地址:

杭州市上城区鲲鹏路369号杭州市妇产科医院行政楼5楼 

Primary sponsor's address:

369 Kunpeng Road, Hangzhou, Zhejiang, 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州市妇产科医院

具体地址:

杭州市上城区鲲鹏路369号杭州市妇产科医院

Institution
hospital:

Hangzhou Women's Hospital

Address:

369 Kunpeng Road, Hangzhou, Zhejiang, China

经费或物资来源:

杭州市科技局社会发展科研主动设计项目 

Source(s) of funding:

Social Development Scientific Research Active Design Projects of the Science and Technology Bureau of Hangzhou 

研究疾病:

无 

Target disease:

none 

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:

建立本地区基于流行病学调查和生物样本的基础健康数据库,开展前瞻性大样本队列研究,探讨本地区主要环境雌激素宫内暴露对婴幼儿的影响 

Objectives of Study:

To establish a regional basic health database and promote a large-sample cohort study. To explore the effects of intrauterine exposure of environmental estrogen disruptors on growth and development of infants and children 

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)在社区卫生服务中心、乡镇卫生院建立过孕产妇保健手册; 2)在我院首次产检孕周≤28周; 3)有意向在本院定期产检和分娩,产后在本地久居; 4)语言表达能力正常,能独立完成调查; 5)无精神病史; 6)愿意参与及配合本次研究。 

Inclusion criteria

1. Pregnant woman, have established the maternal health handbook in community health service center; 2. finished the first maternity check-up in our hospital less than 28 weeks; 3. have regular maternity examination and will deliver baby in our hospital, and have long-term residence in the local area after delivery; 4. have normal language expression ability to complete the investigation independently; 5. have no history of mental illness; 6. agreed to participate in this study. 

排除标准:

无 

Exclusion criteria:

None 

研究实施时间:

Study execute time:

From2018-05-16To  

干预措施:

Interventions:

组别:

Case series

样本量:

2000

Group:

Case series

Sample size:

干预措施:

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):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州市妇产科医院 

单位级别:

三甲 

Institution
hospital:

Hangzhou Women's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

环境雌激素

指标类型:

主要指标 

Outcome:

Environmental Estrogen Disruptors

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子代生长发育指标

指标类型:

主要指标 

Outcome:

Growth and Development of Infants and Children

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠结局

指标类型:

次要指标 

Outcome:

pregnancy outcomes

Type:

Secondary 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:

脐带

Sample Name:

Blood

Tissue:

umbilical cord

人体标本去向

使用后保存 

说明

使用后保存5年

Fate of sample:

Preservation after use 

Note:

Preservation for 5 years after using

标本中文名:

尿液

组织:

胎盘

Sample Name:

urine

Tissue:

placenta

人体标本去向

使用后保存 

说明

使用后保存5年

Fate of sample:

Preservation after use 

Note:

Preservation for 5 years after using

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

观察性研究,无随机方法

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

None

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

试验完成后6个月时,在本网站详细描述试验结果,粘贴发表文章。若需要提供原始数据,可通过邮箱来信要求。ResMan

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

ResMan; 6 months after the completion of the trial, the results will be described in detail on the site, and the articles be posted. Please email the investigator.

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:

本试验有纸质档CRF表,并将数据录入电子采集数据库,定期专人录入数据。

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

This trial has paper files of CRF, and has established an electronic database. Investigators will enter the data regularly.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-24
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