Today is 2019-12-10

Association between first pregnancy and adverse outcomes in subsequent pregnancy
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注册号:

Registration number:

ChiCTR1900027525 

最近更新日期:

Date of Last Refreshed on:

2019-11-17 

注册时间:

Date of Registration:

2019-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

二次妊娠对妊娠结局的影响 

Public title:

Association between first pregnancy and adverse outcomes in subsequent pregnancy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

二次妊娠对妊娠结局的影响:一项多中心回顾性队列研究 

Scientific title:

Association between first pregnancy and adverse outcomes in subsequent pregnancy: a multicenter retrospective cohort study 

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:

吴琰婷 

研究负责人:

黄荷凤 

Applicant:

Yanting Wu 

Study leader:

Hefeng Huang 

申请注册联系人电话:

Applicant telephone:

+86 021 64070434-25517 

研究负责人电话:

Study leader's telephone:

+86 021 64073897 

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:

yanting_wu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huanghefg@sjtu.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:

上海市徐汇区衡山路910号 

研究负责人通讯地址:

上海市徐汇区衡山路910号 

Applicant address:

910 Hengshan Road, Shanghai, China 

Study leader's address:

910 Hengshan Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200030 

研究负责人邮政编码:

Study leader's postcode:

200030 

申请人所在单位:

上海交通大学医学院附属国际和平妇幼保健院  

Applicant's institution:

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University 

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:

国科伦委(GKLW)2019-10 

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:

国际和平妇幼保健院医学科研伦理委员会 

Name of the ethic committee:

Medical Research Ethic Committee of International Peace Maternity and Child Health Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-22 

伦理委员会联系人:

张勇 

Contact Name of the ethic committee:

Yong Zhang 

伦理委员会联系地址:

上海市徐汇区衡山路910号 

Contact Address of the ethic committee:

910 Hengshan Road, Xuhui District, Shanghai, 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:

yzhang415@163.com 

研究实施负责(组长)单位:

上海交通大学医学院附属国际和平妇幼保健院  

Primary sponsor:

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University 

研究实施负责(组长)单位地址:

上海市徐汇区衡山路910号 

Primary sponsor's address:

910 Hengshan Road, Xuhui 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):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

上海交通大学医学院附属国际和平妇幼保健院

具体地址:

衡山路910号

Institution
hospital:

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University

Address:

910 Hengshan Road, Xuhui District

经费或物资来源:

单位自筹 

Source(s) of funding:

Self-financing 

研究疾病:

妊娠结局 

Target disease:

pregnancy outcome 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

调查首次妊娠对随后妊娠母婴结局的影响。 

Objectives of Study:

Investigate the effect of first pregnancy on maternal and infant outcomes in subsequent 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:

连续入组 

Study design:

Sequential 

纳入标准:

1) 2014年6月-2019年6月于研究实施医院进行分娩或流产的经产妇; 2) 孕次 ≥ 2; 3) 产次 ≥ 1,且至少一次活产分娩。 

Inclusion criteria

1) Women who had delivery or abortion in listed hospitals from June 2014 to June 2019; 2) Gravidity >= 2; 2) Parity>= 1 and at least one live birth. 

排除标准:

1) 前次妊娠分娩时间不详; 2) 孕前患有严重全身性疾病,如恶性肿瘤、心脏病、精神疾病等; 3) 外籍; 4) 资料缺失过多。 

Exclusion criteria:

1) The date of previous delivery is unknown; 2) Women with severe systemic diseases, such as cancer, heart diseases, mental diseases, etc.; 3) Foreigners; 4) Too much data missing. 

研究实施时间:

Study execute time:

From2019-12-01To 2021-06-01 

干预措施:

Interventions:

组别:

Case series

样本量:

100000

Group:

Case series

Sample size:

干预措施:

无干预措施

干预措施代码:

Intervention:

No interventions

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):

徐汇 

Country:

China 

Province:

Shanghai 

City:

Xuhui District 

单位(医院):

上海交通大学医学院附属国际和平妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

芜湖 

Country:

China 

Province:

Anhui 

City:

Wuhui 

单位(医院):

芜湖市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhu No.1 People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

南宁 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

Nanning 

单位(医院):

广西壮族自治区妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

The Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

海南 

市(区县):

海口 

Country:

China 

Province:

Hai'nan 

City:

Haikou 

单位(医院):

海南省妇女儿童医学中心 

单位级别:

三级甲等 

Institution
hospital:

Hainan Women and Children's Medical Center  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

海南 

市(区县):

文昌 

Country:

China 

Province:

Hai'nan 

City:

Wenchang 

单位(医院):

文昌市妇幼保健院 

单位级别:

一级甲等 

Institution
hospital:

Wenchang Maternal and Child Health Hospital  

Level of the institution:

Primary A Hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

石家庄 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

石家庄市妇产医院 

单位级别:

三级甲等 

Institution
hospital:

Shijiazhuang Obstetrics and Gynecology Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

湖南省妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Hunan Provincial Maternal and Child Health Care Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江西 

市(区县):

抚州 

Country:

China 

Province:

Jiangxi 

City:

Fuzhou 

单位(医院):

抚州市妇幼保健院 

单位级别:

二级甲等 

Institution
hospital:

Fuzhou Maternal and Child Health Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

大连 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Dalian Maternal and Child Health Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

延安 

Country:

China 

Province:

Shaanxi 

City:

Yan‘an 

单位(医院):

延安大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Yan’an University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

松江 

Country:

China 

Province:

Shanghai 

City:

Songjiang District 

单位(医院):

上海市松江区妇幼保健院 

单位级别:

二级甲等 

Institution
hospital:

Songjiang Maternal and Child Health Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

克拉玛依 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

Keramay 

单位(医院):

新疆克拉玛依市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Karamay Central Hospital of Xinjiang  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

衢州 

Country:

China 

Province:

Zhejiang 

City:

Quzhou 

单位(医院):

常山县人民医院 

单位级别:

三级乙等 

Institution
hospital:

Changshan People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属妇产科医院 

单位级别:

三级甲等 

Institution
hospital:

Women's Hospital School of Medicine Zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

富阳区妇幼保健院 

单位级别:

三级乙等 

Institution
hospital:

Fuyang Maternal and Child Health Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

湖州 

Country:

China 

Province:

Zhejiang 

City:

Huzhou 

单位(医院):

湖州市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Huzhou Maternity and Child Care Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

嘉兴 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉善县妇幼保健院 

单位级别:

三级乙等 

Institution
hospital:

Jiashan Maternity and Child Care Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

嘉兴 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉兴市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Jiaxing Maternity and Child Health Care Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

宁波大学医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Medical School of Ningbo University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

宁波市妇女儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Ningbo Women and Children's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

绍兴 

Country:

China 

Province:

Zhejiang 

City:

Shaoxing 

单位(医院):

绍兴市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Shaoxing Maternity and Child Health Care Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

嵊州 

Country:

China 

Province:

Zhejiang 

City:

Shengzhou 

单位(医院):

嵊州市妇幼保健院 

单位级别:

二级 

Institution
hospital:

Shengzhou Maternity and Child Health Care Hospital  

Level of the institution:

Secondary Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

台州 

Country:

China 

Province:

Zhejiang 

City:

Taizhou 

单位(医院):

台州恩泽妇产医院 

单位级别:

三级甲等 

Institution
hospital:

Taizhou Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Wenzhou People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

郑州大学第三附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Hospital affiliated to Zhengzhou University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

自然流产

指标类型:

主要指标 

Outcome:

spontaneous abortion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

早产

指标类型:

主要指标 

Outcome:

preterm delivery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活产

指标类型:

主要指标 

Outcome:

live birth

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死产

指标类型:

主要指标 

Outcome:

still birth

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

引产

指标类型:

主要指标 

Outcome:

induced labor

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人工流产

指标类型:

主要指标 

Outcome:

induced abortion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠期并发症

指标类型:

主要指标 

Outcome:

pregnancy maternal complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胎儿附属物异常

指标类型:

主要指标 

Outcome:

abnormal fetal appurtenances

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

分娩并发症

指标类型:

主要指标 

Outcome:

labor complications

Type:

Primary 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:

主要指标 

Outcome:

gestational age

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出生体重

指标类型:

主要指标 

Outcome:

birth weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新生儿疾病

指标类型:

主要指标 

Outcome:

Neonatal disease

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出生缺陷

指标类型:

主要指标 

Outcome:

Birth defect

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阿普加评分

指标类型:

主要指标 

Outcome:

Apgar score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会人口学资料

指标类型:

次要指标 

Outcome:

Sociodemographic data

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生育史

指标类型:

次要指标 

Outcome:

childbearing history

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病史

指标类型:

次要指标 

Outcome:

medical history

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

分娩方式

指标类型:

主要指标 

Outcome:

mode of delivery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

避孕史

指标类型:

次要指标 

Outcome:

History of contraception

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

喂养史

指标类型:

次要指标 

Outcome:

Feeding history

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孕期产检

指标类型:

次要指标 

Outcome:

prenatal care visits

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

受孕方式

指标类型:

次要指标 

Outcome:

Mode of conception

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:

标本中文名:

无标本采集

组织:

Sample Name:

No Samples

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 years
最大 Max age 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):

不适用

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

Not applicable

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

项目完成半年后,需要原始数据的人员申请并通过项目委员会批准后将通过加密邮件方式传输给申请人员。

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

The original data will be transmitted to the applicant through encrypted mail after approval by the project committee.

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:

电子采集和管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-17
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