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早孕期筛查及预防子痫前期的临床研究
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注册号:

Registration number:

ChiCTR1800020288 

最近更新日期:

Date of Last Refreshed on:

2018-12-22 

注册时间:

Date of Registration:

2018-12-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

早孕期筛查及预防子痫前期的临床研究 

Public title:

Screening for and preventing preeclampsia at the first trimester 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

早孕期筛查及预防子痫前期的临床研究 

Scientific title:

Screening for and preventing preeclampsia at the first trimester 

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:

郑明明 

研究负责人:

胡娅莉 

Applicant:

Zheng Mingming 

Study leader:

Hu Yali 

申请注册联系人电话:

Applicant telephone:

+86 13813849845 

研究负责人电话:

Study leader's telephone:

+86 13951846008 

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:

zheng_mm@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

glyyhuyali@163.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:

江苏省南京市鼓楼区中山路321号 

研究负责人通讯地址:

江苏省南京市鼓楼区中山路321号 

Applicant address:

321 Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

南京大学医学院附属鼓楼医院 

Applicant's institution:

the Affiliated Drum Tower Hospital of Medical School 

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:

2018-251-01 

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:

南京大学医学院附属鼓楼医院医学伦理委员会  

Name of the ethic committee:

Ethics committee of the Affiliated Drum Tower Hospital of Medical School of Nanjing University  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-07 

伦理委员会联系人:

沙莉莉 

Contact Name of the ethic committee:

Sha Lili 

伦理委员会联系地址:

南京市中山路321号2号楼9楼 

Contact Address of the ethic committee:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

香港威爾斯親王醫院 

Primary sponsor:

Prince of Wales Hospital 

研究实施负责(组长)单位地址:

香港新界沙田銀城街30-32號 威爾斯親王醫院 

Primary sponsor's address:

Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories, Hongkong, 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):

香港

市(区县):

Country:

China

Province:

Hong Kong Special Administrative Region

City:

单位(医院):

香港威爾斯親王醫院

具体地址:

香港新界沙田銀城街30-32號 威爾斯親王醫院

Institution
hospital:

Prince of Wales Hospital

Address:

Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, New Territories

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

子痫前期 

Target disease:

Preeclampsia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评估早孕期筛查和低剂量阿司匹林预防子痫前期的有效性、可接受度和安全性 

Objectives of Study:

Assessing the effectiveness, acceptability, and safety of screening for and low-dose aspirin use for preventing pre-eclampsia at the first trimester 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

年龄>18周岁;单胎妊娠;在孕11-13周时胎儿存活;理解并签署中文或英文同意书 

Inclusion criteria

Aged >18 years; Singleton pregnancy; Live fetus; Understand and sign the Chinese or English consent form 

排除标准:

多胎妊娠;11-13周存在严重胎儿机构畸形;孕11-13周时没有胎心搏动(稽留流产);不能够签署同意书,认知或智力障碍,不能够理解和书写中文或英文。 

Exclusion criteria:

Multiple pregnancy;Major fetal defects identified at 11-13 weeks of assessment; Non-viable fetus (missed spontaneous abortion or stillbirth); Failure to sign consent, cognitive or intellectual disabilities, and inability to understand and write Chinese or English. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

52920

Group:

Case series

Sample size:

干预措施:

口服小剂量阿司匹林

干预措施代码:

Intervention:

low-dose aspirin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

香港 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

香港威爾斯親王醫院 

单位级别:

 

Institution
hospital:

Prince of Wales Hospital  

Level of the institution:

 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

nanjing 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等 

Institution
hospital:

the Affiliated Drum Tower Hospital of Medical School of Nanjing University  

Level of the institution:

Tertiary A hospital 

国家:

新加坡 

省(直辖市):

肯特岗 

市(区县):

 

Country:

Singapore 

Province:

Kent Ridge 

City:

 

单位(医院):

新加坡国立大学医院 

单位级别:

 

Institution
hospital:

National University Hospital  

Level of the institution:

 

国家:

中国 

省(直辖市):

台湾 

市(区县):

 

Country:

China 

Province:

Taiwan 

City:

 

单位(医院):

长庚医院 

单位级别:

 

Institution
hospital:

Chang Gung Hospital  

Level of the institution:

 

国家:

泰国 

省(直辖市):

曼谷 

市(区县):

 

Country:

Thailand 

Province:

Bangkok 

City:

 

单位(医院):

Siriraj Hospital 

单位级别:

 

Institution
hospital:

Siriraj Hospital  

Level of the institution:

 

国家:

菲律宾 

省(直辖市):

马尼拉 

市(区县):

 

Country:

Philippines 

Province:

Ermita 

City:

 

单位(医院):

Philippine General Hospital 

单位级别:

 

Institution
hospital:

Philippine General Hospital  

Level of the institution:

 

国家:

印度尼西亚 

省(直辖市):

雅加达 

市(区县):

 

Country:

Indonesia 

Province:

Harapan Kita Hospital 

City:

 

单位(医院):

Harapan Kita Hospital 

单位级别:

 

Institution
hospital:

Harapan Kita Hospital  

Level of the institution:

 

国家:

马来西亚 

省(直辖市):

吉隆坡 

市(区县):

 

Country:

Malaysia 

Province:

Kuala Lumpur 

City:

 

单位(医院):

Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre 

单位级别:

 

Institution
hospital:

Pusat Perubatan Universiti Kebangsaan Malaysia (UKM) Medical Centre  

Level of the institution:

 

国家:

越南 

省(直辖市):

河内 

市(区县):

 

Country:

Vietnam 

Province:

Hanoi 

City:

 

单位(医院):

Hanoi Obstetrics & Gynecology Hospital 

单位级别:

 

Institution
hospital:

Hanoi Obstetrics & Gynecology Hospital  

Level of the institution:

 

国家:

日本 

省(直辖市):

东京 

市(区县):

 

Country:

Japan 

Province:

Tokyo 

City:

 

单位(医院):

Showa University Hospital 

单位级别:

 

Institution
hospital:

Showa University Hospital  

Level of the institution:

 

国家:

日本 

省(直辖市):

大阪 

市(区县):

 

Country:

Japan 

Province:

Osaka 

City:

 

单位(医院):

Clinical Research Institute of Fetal Medicine Osaka 

单位级别:

 

Institution
hospital:

Clinical Research Institute of Fetal Medicine Osaka  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

11-13+6周、20-24周、30-34周、35-37周

测量方法:

电子血压计间接测量

Measure time point of outcome:

11-13+6 weeks, 20-24 weeks, 30-34 weeks, 35-37 weeks

Measure method:

Indirect measurement of electronic blood pressure monitor

指标中文名:

子宫动脉血流

指标类型:

主要指标 

Outcome:

Indirect measurement of electronic blood pressure monitor

Type:

Primary indicator 

测量时间点:

11-13+6周、20-24周、30-34周、35-37周

测量方法:

多普勒超声

Measure time point of outcome:

11-13+6 weeks, 20-24 weeks, 30-34 weeks, 35-37 weeks

Measure method:

Doppler ultrasound

指标中文名:

血清胎盘生长因子

指标类型:

主要指标 

Outcome:

Placental growth factor

Type:

Primary indicator 

测量时间点:

11-13+6周、20-24周、30-34周、35-37周

测量方法:

免疫荧光法

Measure time point of outcome:

11-13+6 weeks, 20-24 weeks, 30-34 weeks, 35-37 weeks

Measure method:

Immunofluorescence

指标中文名:

可溶性酪氨酸激酶1

指标类型:

主要指标 

Outcome:

sFlt-1

Type:

Primary indicator 

测量时间点:

11-13+6周、20-24周、30-34周、35-37周

测量方法:

免疫荧光法

Measure time point of outcome:

11-13+6 weeks, 20-24 weeks, 30-34 weeks, 35-37 weeks

Measure method:

Immunofluorescence

指标中文名:

妊娠相关蛋白A

指标类型:

主要指标 

Outcome:

PAPP-A

Type:

Primary indicator 

测量时间点:

11-13+6周、20-24周、30-34周、35-37周

测量方法:

免疫荧光法

Measure time point of outcome:

11-13+6 weeks, 20-24 weeks, 30-34 weeks, 35-37 weeks

Measure method:

Immunofluorescence

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):

研究开始前,根据电脑随机产生的数字,所有群组将被随机排序,该 顺序将被隐藏直至该群组试验开始前 3 周。由试验统计员负责随机化分组。

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

All clusters will be randomized according to the computer-generated random numbers and we will conceal each cluster’s random start until 3 weeks before that date. Randomization will be conducted by the trial statistician

盲法:

未说明

Blinding:

Not stated

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):

试验完成后6个月内公开,上传至本网站ResMan

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

IPD will be public accessable via ResMan within six months after the trial complete on this website

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:

数据录入及保存于软件Viewpoint 6.0

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

data will be recorded and reserved in the Viewpoint 6.0

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-12-22
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