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Early identification of histological chorioamnionitis by routine blood parameters in parturients with intrapartum fever
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注册号:

Registration number:

ChiCTR2100053554 

最近更新日期:

Date of Last Refreshed on:

2022-05-18 

注册时间:

Date of Registration:

2021-11-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

产时发热产妇血常规指标对组织学绒毛膜羊膜炎的早期识别 

Public title:

Early identification of histological chorioamnionitis by routine blood parameters in parturients with intrapartum fever 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

产间发热产妇在产程前后变化情况的探究 

Scientific title:

An investigation of the change of maternal fever during interpartum before and after delivery 

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:

徐晨阳 

研究负责人:

范裕如 

Applicant:

Xu Chenyang 

Study leader:

Fan Yuru 

申请注册联系人电话:

Applicant telephone:

+86 13866998974 

研究负责人电话:

Study leader's telephone:

+86 18606190360 

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:

13866998974@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fyr1899@njmu.edu.cn 

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:

江苏省南京市莫愁路天妃巷123号南京市妇幼保健院 

研究负责人通讯地址:

江苏省南京市莫愁路天妃巷123号南京市妇幼保健院 

Applicant address:

123 Tianfei Lane, Mochou Road, Nanjing, Jiangsu 

Study leader's address:

123 Tianfei Lane, Mochou Road, Nanjing, Jiangsu 

申请注册联系人邮政编码:

Applicant postcode:

210001 

研究负责人邮政编码:

Study leader's postcode:

210001 

申请人所在单位:

南京市妇幼保健院 

Applicant's institution:

Nanjing Maternal and Child Health Hospital 

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:

2020KY035 

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:

南京市妇幼保健院医学伦理委员会 

Name of the ethic committee:

Nanjing Maternal and Child Health Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-27 

伦理委员会联系人:

阚延静 

Contact Name of the ethic committee:

Kan Yanjing 

伦理委员会联系地址:

江苏省南京市莫愁路天妃巷123号南京市妇幼保健院医学伦理委员会  

Contact Address of the ethic committee:

123 Tianfei Lane, Mochou Road, Nanjing, Jiangsu 

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:

南京市妇幼保健院 

Primary sponsor:

Nanjing Maternal and Child Health Hospital 

研究实施负责(组长)单位地址:

江苏省南京市莫愁路天妃巷123号南京市妇幼保健院 

Primary sponsor's address:

123 Tianfei Lane, Mochou Road, Nanjing, Jiangsu 

试验主办单位(项目批准或申办者):

Secondary sponsor:

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):

江苏省南京市妇幼保健院

具体地址:

莫愁路天妃巷123号

Institution
hospital:

Nanjing Maternal and Child Health Hospital

Address:

123 Tianfei Lane, Mochou Road

经费或物资来源:

81971045/国家自然科学基金 

Source(s) of funding:

81971045/National Natural Science Foundation of China 

研究疾病:

产时发热 

Target disease:

intrapartum fever 

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

通过对产间发热产妇和正常产妇血常规及其他检查等数据的比较,从而观察产间发热产妇在整个产程中的变化情况,利用易于获取的系统性炎症参数早期识别组织学绒毛膜羊膜炎(HCA)的潜在临床价值。 

Objectives of Study:

By comparing the data of blood routine and other examinations between febrile puerperae and normal puerperae, we can observe the changes of febrile puerperae in the whole labor process. Potential clinical value of early identification of histological chorioamnionitis (HCA) using readily available systemic inflammatory parameters. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

采用硬膜外分娩镇痛出现体温≥38℃的单胎足月孕妇,临床资料完整,均在发热2h内进行血常规检查,分娩后行胎盘病理检查者。 

Inclusion criteria

Singleton full-term pregnant women with body temperature >=38℃ who were treated with epidural labor analgesia, with complete clinical data, underwent blood routine examination within 2 hours of fever, and placenta pathological examination after delivery. 

排除标准:

1.确诊为临床型绒毛膜羊膜炎; 2.入院时合并各种急慢性感染,胎膜早破及其他严重内外科疾病; 3.入院前 1 周内已使用抗生素以及非甾体抗炎药物治疗者。 

Exclusion criteria:

1. Diagnosed with clinical chorioamnionitis; 2. Complicated with various acute and chronic infections, premature rupture of membranes and other serious medical and surgical diseases upon admission; 3. Those who have been treated with antibiotics and non-steroidal anti-inflammatory drugs within 1 week before admission. 

研究实施时间:

Study execute time:

From2021-12-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2021-12-01To 2021-12-31 

干预措施:

Interventions:

组别:

对照组(未合并HCA)

样本量:

1219

Group:

Control group (without HCA)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

观察组(合并HCA)

样本量:

119

Group:

Observation group (with HCA combined)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

南京市妇幼保健院 

单位级别:

三甲 

Institution
hospital:

Nanjing Maternal and Child Health Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood routine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胎盘病理检查

指标类型:

主要指标 

Outcome:

Pathological examination of placenta

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

Temperature

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 45 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):

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

Unused

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

文章

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

Paper

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:

CRF+EDC

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

CRF+EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-24
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