ChiCTR-TRC-12002644 版本V1.0 版本创建时间2015/11/21 10:42:00 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-TRC-12002644 

最近更新日期：

Date of Last Refreshed on：

 2015-04-30 13:14:03 

注册时间：

Date of Registration：

 2012-11-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

External cephalic version for breech presentation: A randomised controlled trial of anaesthetic interventions

Public title：

External cephalic version for breech presentation: A randomised controlled trial of anaesthetic interventions

注册题目简写：

English Acronym：

研究课题的正式科学名称：

External cephalic version for breech presentation: A randomised controlled trial of anaesthetic interventions

Scientific title：

External cephalic version for breech presentation: A randomised controlled trial of anaesthetic interventions.

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：

KHAW Kim Sun 

研究负责人：

KHAW Kim Sun 

Applicant：

KHAW Kim Sun 

Study leader：

KHAW Kim Sun 

申请注册联系人电话：

Applicant telephone：

 +852 26322735

研究负责人电话：

Study leader's
telephone：

+852 26322735

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：

 kimkhaw@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 kimkhaw@gmail.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：

Department of Anaesthesia & Intensive Care. 4/F

研究负责人通讯地址：

Department of Anaesthesia & Intensive Care. 4/F

Applicant address：

Department of Anaesthesia & Intensive Care. 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT

Study leader's address：

Department of Anaesthesia & Intensive Care. 4/F Main Clinical Block & Trauma Centre, Prince of Wales Hospital, Shatin, NT

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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 CRE-2003.065-T

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：

Joint CUHK-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2003-04-01 00:00:00

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：

Research Grants Council of Hong Kong

Primary sponsor：

Research Grants Council of Hong Kong

研究实施负责（组长）单位地址：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, People's Republic of China.

Primary sponsor's address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, People's Republic of China.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Hong Kong

省(直辖市)：

Hong Kong

市(区县)：

Country：

Hong Kong

Province：

Hong Kong

City：

单位(医院)：

Prince of Wales Hospital

具体地址：

Prince of Wales Hospital

Institution
hospital：

Prince of Wales Hospital

Address：

Prince of Wales Hospital

经费或物资来源：

Research Grants Council of Hong Kong

Source(s) of funding：

Research Grants Council of Hong Kong

研究疾病：

Breech Presentation during Pregnancy  

Target disease：

Breech Presentation during Pregnancy

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Our objectives in this prospective randomised blinded control study are to compare the outcome and effects of using (A) intravenous analgesia or (B) spinal anaesthesia for primary and reattempts of ECV at term. Secondary objectives are comparisons of the effects on the fetus, mechanical forces used, pain and side effects during ECV. The conclusion will define the role of using IV analgesia and spinal anaesthesia for ECV, and establish guidelines that are not available in current literature.  

Objectives of Study：

Our objectives in this prospective randomised blinded control study are to compare the outcome and effects of using (A) intravenous analgesia or (B) spinal anaesthesia for primary and reattempts of ECV at term. Secondary objectives are comparisons of the effects on the fetus, mechanical forces used, pain and side effects during ECV. The conclusion will define the role of using IV analgesia and spinal anaesthesia for ECV, and establish guidelines that are not available in current literature.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

NIL 

纳入标准：

All singleton pregnancies suitable to have ECV for breech presentation at or beyond 36 weeks of gestation will be assessed for eligibility for inclusion. 24;25;27;40 ECVs for transverse lie, unstable lie, or second twin will be excluded for the purpose of this study. Patients suitable for this study would be in good health (ASA 1-2), and those contraindicated to have spinal anaesthesia or IV analgesia will be excluded. Informed written consent will obtained from all patients, before commencement of study.

Inclusion criteria

All singleton pregnancies suitable to have ECV for breech presentation at or beyond 36 weeks of gestation will be assessed for eligibility for inclusion. 24;25;27;40 ECVs for transverse lie, unstable lie, or second twin will be excluded for the purpose of this study. Patients suitable for this study would be in good health (ASA 1-2), and those contraindicated to have spinal anaesthesia or IV analgesia will be excluded. Informed written consent will obtained from all patients, before commencement of study.

排除标准：

NA

Exclusion criteria：

NA

研究实施时间：

Study execute time：

从 From 2003-05-01 00:00:00至 To 2008-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2003-05-01 00:00:00 至 To 2008-10-01 00:00:00

干预措施：

Interventions：

组别：

样本量：

 63

Group：

3

Sample size：

干预措施：

干预措施代码：

Intervention：

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 Prince of Wales Hospital 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

Successful ECV

指标类型：

主要指标

Outcome：

Successful ECV

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 岁 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）：

Random Shuffled coded envelope

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

Random Shuffled coded envelope

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

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）：

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

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：

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2012-11-05 00:00:00