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The effect of maternal depression on the development of nervous system of offspring
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注册号:

Registration number:

ChiCTR1900020697 

最近更新日期:

Date of Last Refreshed on:

2019-01-14 

注册时间:

Date of Registration:

2019-01-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

母亲抑郁焦虑情绪对后代神经系统发育的影响 

Public title:

The effect of maternal depression on the development of nervous system of offspring 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

母亲抑郁焦虑情绪对婴儿大脑微结构的影响及其作用机制 

Scientific title:

The effect of maternal depression on the brain microstructure of infants and its mechanism involved with 

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:

杨建辉 

研究负责人:

黄月君 

Applicant:

Jianhui Yang 

Study leader:

Yuejun Huang 

申请注册联系人电话:

Applicant telephone:

+86 13509879424 

研究负责人电话:

Study leader's telephone:

+86 18675429800 

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:

doublecheese.yjh@foxmail.com 

研究负责人电子邮件:

Study leader's E-mail:

moon_hyj@qq.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:

广东省汕头市东厦北路69号 

研究负责人通讯地址:

广东省汕头市东厦北路69号 

Applicant address:

69 Dongxia Road North, Shantou, Guangdong, China 

Study leader's address:

69 Dongxia Road North, Shantou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

515041 

研究负责人邮政编码:

Study leader's postcode:

515041 

申请人所在单位:

广东省汕头市汕头大学医学院第二附属医院 

Applicant's institution:

Second Affiliated Hospital of Shantou University Medical College 

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:

汕大医附二(2017)伦受(科)第(34)号 

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:

汕头大学医学院附属第二医院伦理委员会 

Name of the ethic committee:

Research Ethics Committee of Second Affiliated Hospital of Shantou University Medical College  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-23 

伦理委员会联系人:

杨翠丹 

Contact Name of the ethic committee:

Cuidan Yang 

伦理委员会联系地址:

广东省汕头市东厦北路69号,汕头大学医学院第二附属医院 

Contact Address of the ethic committee:

69 Dongxia Road North, Shantou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

0754-88915807 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sdyfeyllb@163.com 

研究实施负责(组长)单位:

汕头大学医学院第二附属医院 

Primary sponsor:

Second Affiliated Hospital of Shantou University Medical College 

研究实施负责(组长)单位地址:

广东省汕头市东厦北路69号 

Primary sponsor's address:

69 Dongxia Road North, Shantou, Guangdong, 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):

广东

市(区县):

汕头

Country:

China

Province:

Guangdong

City:

Shantou

单位(医院):

汕头大学医学院第二附属医院

具体地址:

广东省汕头市东厦北路69号

Institution
hospital:

Second Affiliated Hospital of Shantou University Medical College

Address:

69 North Dongxia Road,Shantou,Guangdong,China

经费或物资来源:

国家自然科学基金项目 

Source(s) of funding:

National Natural Science Foundation of China (NSFC) 

研究疾病:

儿童神经行为疾病;大脑神经微结构 

Target disease:

child neurobehavioral disorders; Neural microstructure of the brain 

研究疾病代码:

Target disease code:

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

建立前瞻性队列研究,以孕早期妇女为研究对象,分析母体孕前、孕期、分娩后的抑郁焦虑情绪,监测皮质激素和甲状腺激素的变化,检测胎盘相关基因DNA甲基化情况,对后代进行磁共振脑影像数据的收集,评估1月龄婴儿大脑神经微结构,随访后代至3岁,收集体格生长发育和神经行为发育资料。结合动物研究和临床研究结果,全面分析母亲抑郁焦虑情绪对后代神经系统发育的影像。 

Objectives of Study:

The prospective cohort study will be established, which object is the pregnant woman in early pregnancy. We will analyze the mental condition of gestational women at three trimesters of pregnancy maternal pregnancy and after labor, and detect the levels of cortical hormone and thyroid hormone. The DNA methylation of placenta will detect after the pregnancy women delivery. The brain microstructure of infants will assess by 3T MRI when the infants are 1 month old. The infants will be follow-up to 6 months, and physical growth and neurobehavioral development information of the infants are collected each month. Combined with the results of animal research and clinical research, we can analyze comprehensively the relationship between maternal depression and brain microstructure of infants and its mechanism involved with. 

药物成份或治疗方案详述:

无 

Description for medicine or protocol of treatment in detail:

N/A 

研究设计:

巢式病例-对照研究 

Study design:

Nested case-control study 

纳入标准:

孕期妇女 

Inclusion criteria

Pregnancy women 

排除标准:

1.存在营养不良及重大躯体疾病者; 2.孕期需要服用药物者。 

Exclusion criteria:

1. Pregnancy women with malnutrition and major physical diseases; 2. Description medicine during pregnancy. 

研究实施时间:

Study execute time:

From2019-08-01To 2024-07-31 

干预措施:

Interventions:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

汕头 

Country:

China 

Province:

Guangdong 

City:

Shantou 

单位(医院):

汕头大学医学院第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Shantou University Medical College  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

胎盘激素DNA甲基化水平

指标类型:

主要指标 

Outcome:

DNA methylation level of placental hormone

Type:

Primary indicator 

测量时间点:

观察对象分娩后1个月内

测量方法:

亚硫酸氢盐处理后测序

Measure time point of outcome:

within 1 month after delivery

Measure method:

bisulfite sequencing PCR

指标中文名:

抑郁自评量表得分

指标类型:

主要指标 

Outcome:

SDS-score

Type:

Primary indicator 

测量时间点:

妊娠三期及哺乳期

测量方法:

量表评估

Measure time point of outcome:

Three trimester of pregnancy and breast feeding peroid

Measure method:

Assessment Scale

指标中文名:

焦虑自评量表得分

指标类型:

主要指标 

Outcome:

SAS-score

Type:

Primary indicator 

测量时间点:

妊娠三期及哺乳期

测量方法:

量表评估

Measure time point of outcome:

Three trimester of pregnancy and breast feeding peroid

Measure method:

Assessment Scale

指标中文名:

匹兹堡睡眠质量指数

指标类型:

主要指标 

Outcome:

Pittsburgh sleep quality index

Type:

Primary indicator 

测量时间点:

妊娠三期及哺乳期

测量方法:

量表评估

Measure time point of outcome:

Three trimester of pregnancy and breast feeding peroid

Measure method:

Assessment Scale

指标中文名:

胎儿出生体重

指标类型:

次要指标 

Outcome:

fetal birth weight

Type:

Secondary indicator 

测量时间点:

胎儿娩出后1小时内

测量方法:

Measure time point of outcome:

within 1 hour after delivery

Measure method:

指标中文名:

婴幼儿体格生长数据

指标类型:

次要指标 

Outcome:

physical growth data of infant

Type:

Secondary indicator 

测量时间点:

出生后定期随访

测量方法:

Measure time point of outcome:

regular follow-up after birth

Measure method:

指标中文名:

Gesell量表

指标类型:

主要指标 

Outcome:

Gesell-score

Type:

Primary indicator 

测量时间点:

出生后与体格生长数据同期评估

测量方法:

量表评估

Measure time point of outcome:

the same time of the physical growth

Measure method:

Assessment scale

指标中文名:

新生儿神经行为测定评分

指标类型:

主要指标 

Outcome:

NBNA-score

Type:

Primary indicator 

测量时间点:

生后28天

测量方法:

量表评估

Measure time point of outcome:

28 days after birth

Measure method:

Assessment scale

指标中文名:

大脑微结构

指标类型:

主要指标 

Outcome:

brain microstructure

Type:

Primary indicator 

测量时间点:

生后1月龄

测量方法:

磁共振(神经突起内分散度和密度成像)

Measure time point of outcome:

1 month after birth

Measure method:

MRI (NODDI)

指标中文名:

一般资料(母亲教育水平、吸烟、饮酒、药物滥用史、家庭收入、婴儿喂养情况等)

指标类型:

次要指标 

Outcome:

General information (maternal education level, smoking, drinking, history of substance abuse, household income, infant feeding, etc.)

Type:

Secondary indicator 

测量时间点:

婴儿生后6月内

测量方法:

问卷

Measure time point of outcome:

Within 6 months of infant

Measure method:

Questionnaire

指标中文名:

生活事件量表

指标类型:

次要指标 

Outcome:

Life event scale

Type:

Secondary indicator 

测量时间点:

妊娠三期和哺乳期

测量方法:

量表评估

Measure time point of outcome:

Three trimester of pregnancy and breast feeding peroid

Measure method:

Assessment scale

指标中文名:

艾森克个性测验

指标类型:

次要指标 

Outcome:

Eysenck personality questionnaire

Type:

Secondary indicator 

测量时间点:

妊娠三期和哺乳期

测量方法:

量表评估

Measure time point of outcome:

Three trimester of pregnancy and breast feeding peroid

Measure method:

Assessment scale

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

绒毛膜滋养层组织

组织:

胎盘

Sample Name:

chorion trophoblastic tissue

Tissue:

placenta

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 - 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):

本试验类型为队列研究和巢式病例对照研究,无需进行随机分组。

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

The trials are cohort studies and nested case-control studies, so it do not need randomization.

盲法:

未说明

Blinding:

Not stated

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):

将按照文章所投杂志要求上传原始数据

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

The original data will be uploaded according to the magazine's requirements

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:

在临床研究病例记录表收集入组对象基线数据及结局并传输至临床研究电子管理公共平台

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

Collect the baseline and outcome of enrolled subjects in Case Record Form and transfer the data to Clinical Trial Management Public Platform(ResMan).

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-14
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