今天是:2019-08-21 星期三

北京人群妊娠相关静脉血栓栓塞症风险评估量表建立及临床应用研究
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注册号:

Registration number:

ChiCTR1800015848 

最近更新日期:

Date of Last Refreshed on:

2018-04-24 

注册时间:

Date of Registration:

2018-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

北京人群妊娠相关静脉血栓栓塞症风险评估量表建立及临床应用研究 

Public title:

Establishment of a risk assessment tool for pregnancy-associated venous thromboembolism and its clinical application in Beijing 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

妊娠及产褥期静脉血栓栓塞症风险评估量表建立及临床应用研究 

Scientific title:

Establishment of a risk assessment tool for pregnancy-associated venous thromboembolism and its clinical application in Beijing 

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:

 

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:

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 

研究负责人通讯地址:

北京市朝阳区姚家园路251号 

Applicant address:

251 Yaojiayuan Road, Chaoyang District, Beijing, China 

Study leader's address:

251 Yaojiayuan Road, Chaoyang District, Beijing, 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:

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:

IEC-B-03-V01-FJ1 

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 & Gynecology hospital affiliated to capital medical university 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-12 

伦理委员会联系人:

张迎媛 

Contact Name of the ethic committee:

ZHANG YINGYUAN 

伦理委员会联系地址:

北京市朝阳区姚家园路251号 

Contact Address of the ethic committee:

251 Yaojiayuan Road, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 68717373-6521 

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:

首都医科大学附属北京妇产医院 

Primary sponsor:

Beijing Obstetrics & Gynecology Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市朝阳区姚家园路251号 

Primary sponsor's address:

251 Yaojiayuan Road, Chaoyang 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# YAO JIA YUAN Road,Chao Yang District,Beijing,China

经费或物资来源:

首都医科大学附属北京妇产医院 

Source(s) of funding:

Beijing Obstetrics & Gynecology Hospital, Capital Medical University 

研究疾病:

妊娠相关血栓栓塞症 

Target disease:

pregnancy-associated venous thromboembolism 

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:

本项目试图明确中国人群妊娠及产褥期VTE风险因素,制定适合中国人群的妊娠相关VTE风险评估量表,为进一步建立评估管理体系及进行预防性干预提供依据。 

Objectives of Study:

Our study aim to identify the risk factors for VTE during pregnancy and puerperal periods, and to develop a pregnancy-associated VTE risk assessment tool suitable for the Chinese population. This will provide a foundation for the further establishment of an assessment and management system in order to provide guidelines to prevent and treat pregnancy-associated VTE. 

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2018年6月-2019年12月招募在首都医科大学附属北京妇产医院建档、产检并分娩的孕妇4420例建立观察性队列,要求了解研究意义自愿参与,对研究人员的观察和评价有良好的依从性,签署知情同意书后均纳入观察队列,能完成孕期定期产检,并随访至产后6周。 

Inclusion criteria

Pregnant patients who visit the Beijing Maternity Hospital affiliated with Capital Medical University between June 2018 and December 2019 will be invited to participate in this observational cohort study with a target number of 4,420 patients. Patient enrollment will be voluntary and involve detailed observations and evaluation. Patients will sign the informed consent for regular prenatal and follow-up examinations until 6 weeks postpartum. 

排除标准:

1) 孕12周之前胎停育的妊娠女性。2)严重的心、肝、肾等重要脏器及血液、免疫系统严重疾病的妊娠女性。 

Exclusion criteria:

1) Miscarriage before 12 weeks of gestational age; and 2) severe heart, liver, or kidney dysfunction, as well as hematologic or immune system disorders. 

研究实施时间:

Study execute time:

From2018-06-01To 2021-06-01 

干预措施:

Interventions:

组别:

Pregnancy population

样本量:

4420

Group:

Pregnancy population

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):

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 

Institution
hospital:

Beijing Obstetrics & Gynecology Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

双下肢加压超声

指标类型:

主要指标 

Outcome:

Complete Compression ultrasound

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:

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:

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

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

cohort

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):

学术会议

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

academic conference

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:

采用专人负责招募病人,运用病历记录表记录数据,并录入电脑管理系统。

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

The special person is responsible for recruiting patients, using the medical record chart (CRF)to record the data, and entering into the computer management system.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-04-24
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