今天是:2020-08-03 星期一

多胎妊娠减胎术对出生子代健康影响的研究
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注册号:

Registration number:

ChiCTR2000029289 

最近更新日期:

Date of Last Refreshed on:

2020-01-21 

注册时间:

Date of Registration:

2020-01-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多胎妊娠减胎术对出生子代健康影响的研究 

Public title:

Study for the impact of multifetal pregnancy reduction on children health 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多胎妊娠减胎术对出生子代健康影响的研究 

Scientific title:

Study for the impact of multifetal pregnancy reduction on children health 

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:

朱依敏 

研究负责人:

朱依敏 

Applicant:

Zhu Yimin 

Study leader:

Zhu Yimin 

申请注册联系人电话:

Applicant telephone:

+86 136058128661 

研究负责人电话:

Study leader's telephone:

+86 136058128661 

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:

tangminyue1124@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhuyim@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:

浙江省杭州市学士路1号浙江大学医学院附属妇产科医院 

研究负责人通讯地址:

浙江省杭州市学士路1号浙江大学医学院附属妇产科医院 

Applicant address:

1 Xueshi Road, Hangzhou, Zhejiang, China 

Study leader's address:

1 Xueshi 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:

浙江大学医学院附属妇产科医院 

Applicant's institution:

Women's Hospital, Zhejiang University School of medicine 

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:

20181076 

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:

浙江大学医学院附属妇产科医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics committee of Women's Hospital, Zhejiang University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-27 

伦理委员会联系人:

唐国静 

Contact Name of the ethic committee:

Tang Guojing 

伦理委员会联系地址:

浙江省杭州市学士路1号浙江大学医学院附属妇产科医院 

Contact Address of the ethic committee:

Women's Hospital, Zhejiang University School of Medicine, 1 Xueshi 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:

浙江大学医学院附属妇产科医院 

Primary sponsor:

Women's Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江大学医学院附属妇产科医院 

Primary sponsor's address:

1 Xueshi 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

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属妇产科医院

具体地址:

浙江省杭州市学士路1号

Institution
hospital:

Women’s hospital, Zhejiang University School of Medicine

Address:

1 Xueshi Road, Hangzhou, Zhejiang, China

经费或物资来源:

省卫生厅省部共建项目 

Source(s) of funding:

Zhejiang Provincial & Ministry of Health Research Fund for Medical Sciences 

研究疾病:

多胎妊娠减胎术 

Target disease:

Mutifetal pregnancy reduction 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

多胎妊娠减胎术对出生子代健康影响的研究 

Objectives of Study:

Aims to study the impact of multifetal pregnancy reduction on children healthy 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

由于多胎妊娠在浙江大学附属妇产科医院进行减胎手术的孕妇的子代 

Inclusion criteria

Offspring of women who underwent reduction in women's hospital, school of medicine,zhejiang university. 

排除标准:

根据现有资料无法联系上,拒绝参加本研究 

Exclusion criteria:

Unable to be contacted because lack of communication information; refused to admit into this study;  

研究实施时间:

Study execute time:

From2020-02-01To 2023-02-01 

征募观察对象时间:

Recruiting time:

From2020-02-01To 2021-12-31 

干预措施:

Interventions:

组别:

减胎组

样本量:

300

Group:

Reduction group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

未减胎组

样本量:

300

Group:

Without reduction group

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):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hanghzou 

单位(医院):

浙江大学医学院附属妇产科医院 

单位级别:

三级甲等 

Institution
hospital:

Women's Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

智商

指标类型:

主要指标 

Outcome:

IQ

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏功能

指标类型:

主要指标 

Outcome:

cardiac function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

主要指标 

Outcome:

renal function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

主要指标 

Outcome:

liver function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能

指标类型:

主要指标 

Outcome:

cognitive development

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管功能

指标类型:

主要指标 

Outcome:

vascular fucntion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生长发育

指标类型:

主要指标 

Outcome:

growth and development

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:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 3 years
最大 Max age 13 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):

NA

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

N/A

盲法:

N/A

Blinding:

N/A

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):

原始数据上传至公共数据库

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

On public database

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:

数据收集和保存与本单位电子采集与管理系统

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

Data collection and preservation with the hospital's electronic collection and management system

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-01-20
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