妊娠末期体位改变对蛛网膜下腔容积的的影响

注册号:

Registration number:

ChiCTR-ONC-14004868 

最近更新日期:

Date of Last Refreshed on:

2017-02-02 15:54:57 

注册时间:

Date of Registration:

2014-06-28 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

妊娠末期体位改变对蛛网膜下腔容积的的影响

Public title:

The influence of body position change on the subarachnoid space volume in the Late pregnancy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

妊娠末期体位改变对蛛网膜下腔容积的的影响

Scientific title:

The influence of body position change on the subarachnoid space volume in the Late pregnancy

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:

续飞 

研究负责人:

续飞 

Applicant:

Fei xu 

Study leader:

Fei xu 

申请注册联系人电话:

Applicant telephone:

+86 010 82267260

研究负责人电话:

Study leader's
telephone:

+86 010 82267260

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:

runningmanmz@126.com

研究负责人电子邮件:

Study leader's E-mail:

runningmanmz@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:

北京市海淀区花园北路49号

研究负责人通讯地址:

北京市海淀区花园北路49号

Applicant address:

No.49, Huanyuanbeilu Street, Haidian District, Beijing, 100191, China

Study leader's address:

No.49, Huanyuanbeilu Street, Haidian District, Beijing, 100191, China.

申请注册联系人邮政编码:

Applicant postcode:

100191

研究负责人邮政编码:

Study leader's postcode:

100191

申请人所在单位:

北京大学第三医院

Applicant's institution:

Peking University Third Hospital

研究负责人所在单位:

北京大学第三医院

Affiliation of the Leader:

Peking University Third Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2014-153

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:

北京大学第三医院医学科学研究伦理委员会

Name of the ethic committee:

Peking University Third Hospital Medical Science Research Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2014-06-19 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:

北京大学第三医院

Primary sponsor:

Peking University Third Hospital

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号

Primary sponsor's address:

No.49, Huanyuanbeilu Street, Haidian District, Beijing

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):

北京大学第三医院

具体地址:

北京市海淀区花园北路49号

Institution
hospital:

Peking University Third Hospital

Address:

No.49, Huanyuanbeilu Street, Haidian District, Bei

经费或物资来源:

临床重点专科建设项目

Source(s) of funding:

the construction project of Clinical key subject

研究疾病:

产科麻醉  

Target disease:

Obstetrics Anesthesia

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

研究设计:

单臂 

Study design:

Single arm 

研究目的:

观察妊娠末期体位改变对蛛网膜下腔容积的影响,来探讨妊娠后腰麻用药量减少及麻醉阻滞平面易向头侧扩散的机理。  

Objectives of Study:

Pregnancy is associated with a facilitated spread of spinal and epidural anesthesia and the dose is also decreased, but the mechanism is unclear, we want to explore the mechanism by observing the influence of body position change on the subarachnoid space volume in the Late pregnancy.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

脊柱畸形
有腰椎疾病
以前磁共振检查脊椎有异常
妊高症患者
理解障碍,无法配合

Exclusion criteria:

spine malformation;
lumbar diseases;
Spine with abnormity and was verified by magnetic resonance;
pregnancy-induced hypertension;
Understanding obstacle, unable to cooperate.

研究实施时间:

Study execute time:

From 2014-06-01 00:00:00 To 2015-06-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2014-07-10 00:00:00 To 2015-03-01 00:00:00

干预措施:

Interventions:

组别:

连续病例

样本量:

18

Group:

Case series

Sample size:

干预措施:

改变体位

干预措施代码:

Intervention:

body position change

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):

北京大学第三医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University third hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

仰卧位和侧卧位情况下胸段和腰段(从T11-12到L5-S1)的轴向和矢状位图像

指标类型:

主要指标

Outcome:

The axial and sagittal images of spine form T11-12

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

次要指标

Outcome:

age

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

次要指标

Outcome:

height

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标

Outcome:

weight

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孕周

指标类型:

次要指标

Outcome:

gestational weeks

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰围

指标类型:

次要指标

Outcome:

waistlin

Type:

Secondary 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 20 years
最大 Max age 35 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):

N/A

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

N/A

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

否No

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):

Not stated

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:

Not stated

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2014-06-30 00:00:00