今天是:2020-11-25 星期三

该试验尚未获伦理委员会批准,请于批准后才开始征募参试者,并与我们联系上传伦理批件。 羟氯喹治疗“抗心磷脂抗体阳性的非典型抗磷脂综合征”致复发性自然流产的随机对照研究
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注册号:

Registration number:

ChiCTR2000035947 

最近更新日期:

Date of Last Refreshed on:

2020-08-20 

注册时间:

Date of Registration:

2020-08-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该试验尚未获伦理委员会批准,请于批准后才开始征募参试者,并与我们联系上传伦理批件。 羟氯喹治疗“抗心磷脂抗体阳性的非典型抗磷脂综合征”致复发性自然流产的随机对照研究 

Public title:

A randomized controlled trial of hydroxychloroquine in the treatment of recurrent spontaneous abortion resulted from ''atypical antiphospholipid syndrome with positive anticardiolipin antibodies'' 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

羟氯喹治疗“抗心磷脂抗体阳性的非典型抗磷脂综合征”致复发性自然流产 的随机对照研究 

Scientific title:

A randomized controlled trial of hydroxychloroquine in the treatment of recurrent spontaneous abortion resulted from ''atypical antiphospholipid syndrome with positive anticardiolipin antibodies'' 

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:

贺银燕 

研究负责人:

贺银燕 

Applicant:

Yinyan He 

Study leader:

Yinyan He 

申请注册联系人电话:

Applicant telephone:

+86 18939761117 

研究负责人电话:

Study leader's telephone:

+86 18939761117 

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:

amelie0228@126.com 

研究负责人电子邮件:

Study leader's E-mail:

amelie0228@126.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:

上海市虹口区海宁路100号 

研究负责人通讯地址:

上海市虹口区海宁路100号 

Applicant address:

100 Hai'ning Road, Hongkou District, Shanghai, China 

Study leader's address:

100 Hai'ning Road, Hongkou District, Shanghai, 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:

上海市第一人民医院 

Applicant's institution:

Shanghai General Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海市第一人民医院 

Primary sponsor:

Shanghai General Hospital 

研究实施负责(组长)单位地址:

上海市虹口区海宁路100号 

Primary sponsor's address:

100 Hai'ning Road, Hongkou District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第一人民医院

具体地址:

上海市虹口区海宁路100号

Institution
hospital:

Shanghai General Hospital

Address:

100 Hai'ning Road, Hongkou District

经费或物资来源:

上海市第一人民医院临床研究创新团队建设项目基金 

Source(s) of funding:

Fund for the construction of clinical research innovation team of Shanghai First People's Hospital 

研究疾病:

抗心磷脂抗体阳性的非典型抗磷脂综合征”致复发性自然流产 

Target disease:

Recurrent spontaneous abortion due to atypical antiphospholipid antibody positive syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.阐述羟氯喹治疗ACA阳性非典型APS早孕患者的有效性、促进妊娠的成功率/保胎成功率; 2.阐述羟氯喹治疗ACA阳性非典型APS早孕患者的安全性; 3.初步建立ACA阳性非典型APS早孕治疗的治疗方案; 

Objectives of Study:

1. To describe the effectiveness of hydroxychloroquine in the treatment of ACA positive atypical APS early pregnancy, and the success rate of pregnancy promotion/fetal protection; 2. To describe the safety of hydroxychloroquine in the treatment of ACA positive atypical APS early pregnancy; 3. Preliminary establishment of a treatment plan for ACA positive atypical APS early pregnancy; 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

不同剂量对照 

Study design:

Dose comparison 

纳入标准:

1)年龄20-35岁的已婚女性; 2)符合ACA阳性非典型APS诊断标准;  

Inclusion criteria

1) Married women aged 20 to 35 years; 2) Meet ACA positive atypical APS diagnostic criteria. 

排除标准:

1)孕酮<20ng/ml 2)抗狼疮抗凝物(LA)阳性 3)不符合本病诊断标准者 4)合并生殖系统肿瘤及畸形者 5)合并心脑肝肾等严重疾患及精神异常者 6)夫妇双方染色体异常血型不合者 7)内分泌功能异常者 8)优生优育试验提示巨细胞病毒、弓形虫病毒、风疹病毒、单纯疱疹病毒感染者; 9)封闭抗体异常者; 10)丈夫精液异常者; 11)近期曾采用同类药物医治,或服用过相关或相拮抗作用的药物,致药物疗效难以判别者; 

Exclusion criteria:

1) Progesterone <20ng/ml; 2) Positive anti-lupus anticoagulant (LA); 3) Those who do not meet the diagnostic criteria for this disease; 4) Patients with reproductive system tumors and malformations; 5) Patients with severe diseases such as heart, brain, liver and kidney and abnormal mental state; 6) Chromosomal abnormalities and blood type incompatibility between the husband and wife; 7) Abnormal endocrine function; 8) The eugenics and eugenics test suggested cytomegalovirus, Toxoplasma virus, rubella virus and herpes simplex virus infection; 9) Abnormal blocking antibody; 10) Abnormal semen of the husband; 11) Those who have recently used similar drugs for treatment, or taken drugs with related or antagonistic effects, resulting in the difficulty in determining the efficacy of drugs. 

研究实施时间:

Study execute time:

From2020-10-01To 2023-09-30 

征募观察对象时间:

Recruiting time:

From2020-09-30To 2022-09-30 

干预措施:

Interventions:

组别:

对照组

样本量:

78

Group:

Control group

Sample size:

干预措施:

达芙通:10mg,q8h,口服

干预措施代码:

Intervention:

Daphone: 10mg, Q8h, oral

Intervention code:

组别:

羟氯喹组1组

样本量:

78

Group:

Hydroxychloroquine group 1

Sample size:

干预措施:

羟氯喹200mg/天+达芙通口服

干预措施代码:

Intervention:

hydroxychloroquine 200mg/ day + Dafotone orally

Intervention code:

组别:

羟氯喹组2组

样本量:

78

Group:

Hydroxychloroquine group 2

Sample size:

干预措施:

羟氯喹200mg/天+达芙通+阿司匹林(50mg/d)口服

干预措施代码:

Intervention:

hydroxychloroquine 200mg/ day + Daphne + aspirin (50mg/ day) orally

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

ACA及相关抗体

指标类型:

主要指标 

Outcome:

ACA and related antibodies

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能指标

指标类型:

主要指标 

Outcome:

Indicators of coagulation function

Type:

Primary indicator 

测量时间点:

每周一次

测量方法:

Measure time point of outcome:

Every week

Measure method:

指标中文名:

妊娠相关激素指标

指标类型:

主要指标 

Outcome:

Pregnancy-related hormone indicators

Type:

Primary indicator 

测量时间点:

每周一次

测量方法:

Measure time point of outcome:

Every week

Measure method:

指标中文名:

胎儿生长发育相关指标

指标类型:

主要指标 

Outcome:

Fetal growth and development related indicators

Type:

Primary indicator 

测量时间点:

每月一次

测量方法:

Measure time point of outcome:

Every month

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 20 years
最大 Max age 35 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):

N/A

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

N/A

盲法:

OPEN

Blinding:

OPEN

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):

暂未定

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

Not stated

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-08-20
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