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微信公众平台开展健康教育对改善母乳喂养的效果研究
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注册号:

Registration number:

ChiCTR1800017364 

最近更新日期:

Date of Last Refreshed on:

2018-07-26 

注册时间:

Date of Registration:

2018-07-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

微信公众平台开展健康教育对改善母乳喂养的效果研究 

Public title:

Effectiveness of Wechat health education on improve breastfeeding 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

微信公众平台开展健康教育对改善母乳喂养的效果研究 

Scientific title:

Effectiveness of Wechat health education on improve breastfeeding 

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:

吴琼 

研究负责人:

吴琼 

Applicant:

Wu Qiong 

Study leader:

Wu Qiong 

申请注册联系人电话:

Applicant telephone:

+86 15001352418 

研究负责人电话:

Study leader's telephone:

+86 15001352418 

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:

wuqiong063@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wuqiong063@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:

北京市朝阳区雅宝路2号 

研究负责人通讯地址:

北京市朝阳区雅宝路2号 

Applicant address:

2 Yabao Road, Chaoyang District, Beijing, China 

Study leader's address:

2 Yabao Road, Chaoyang District, Beijing, China 

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:

首都儿科研究所 

Applicant's institution:

Capital Institute of Pediatrics 

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:

SHERLL2018016 

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:

首都儿科研究所伦理委员会 

Name of the ethic committee:

Ethics Committee of Capital Institute of Pediatrics  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-07-10 

伦理委员会联系人:

杨健 

Contact Name of the ethic committee:

Yang Jian 

伦理委员会联系地址:

北京市朝阳区雅宝路2号 

Contact Address of the ethic committee:

2 Yabao Road, Chaoyang District, Beijing, 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:

 

研究实施负责(组长)单位:

首都儿科研究所 

Primary sponsor:

Capital Institute of Pediatrics 

研究实施负责(组长)单位地址:

北京市朝阳区雅宝路2号 

Primary sponsor's address:

2 Yabao Road, Chaoyang District, Beijing, 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):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

首都儿科研究所

具体地址:

北京市朝阳区雅宝路2号

Institution
hospital:

Capital Institute of Pediatrics

Address:

2 Yabao Road, Chaoyang District, Beijing

经费或物资来源:

联合国儿童基金会 

Source(s) of funding:

UNICEF 

研究疾病:

母乳喂养 

Target disease:

Breastfeeding 

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:

卫生服务研究 

Study phase:

Health Services Research 

研究目的:

探索在青海农村地区开展微信健康教育的可行性,评估微信健康教育提高纯母乳喂养率和母乳为主喂养率、延长母乳喂养时间的效果并评估微信收集数据的质量。 

Objectives of Study:

To explore the feasibility of WeChat education in rural areas Qinghai; to evaluate WeChat education on imporving exclusive breastfeeding and prolonging breastfeeding duration. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄满18周岁或以上的初次妊娠者; (2)研究地区孕中晚期(孕周大于或等于14周、小于37周)的单胎妊娠者; (6)能用普通话正常阅读和交流,并能通过手机使用微信,且具备一定的上网条件; (7)知情同意并可以积极配合。 

Inclusion criteria

1. The first-time mother aged 18 years old or above; 2. 14 -36 weeks pregnant and conceive a singleton fetus; 3. Can read and communicate in Mandarin, and can use Wechat through smart phone, and have internet conditions; 4. Inform consent and cooperate actively. 

排除标准:

孕妇排除标准: (1)多胎妊娠或者非初次妊娠者; (2) 孕周小于14周的孕早期孕妇或孕周大于37周的足月孕妇; (3)拒绝提供手机号码和(或)微信号和(或)无法用电话进行随访的孕妇; (4)无法用普通话正常阅读和交流,不能通过手机使用微信,或无法上网者; (5)怀孕期间和之后一年都不计划在互助县居住的孕妇; (6)伴有严重疾病和妊娠并发症的孕妇,如心脑血管疾病、肺炎和先兆流产等; (7)感染HIV-1的孕妇; (8)不愿意参加的孕妇。 分娩后排除标准: (1)孕妇分娩后出现严重并发症影响母乳喂养的,如急性子宫内翻、产后大出血或产后抑郁等; (2)婴儿出生后入住新生儿重症监护室或1和5分钟Apgar评分<6分,出生体重过低(<2500克)或早产(孕周<37周)的; (3)婴儿出生后被诊断为腭裂或其他先天畸形影响母乳喂养的; (4)婴儿出生后搬离互助县或不在互助县生活的。 (5)有预期的会阻碍母乳喂养的乳腺疾病或其他疾病; (6)近1年内有长期外出计划; (7)1年内有换手机号码的打算并且可通过电话进行随访的; 

Exclusion criteria:

Pregnancy exclusion criteria: 1. Pregnant women with severe disease and complications of pregnancy, such as cerebrovascular diseases, pneumonia and threatened abortion; 2. Pregnant women with HIV-1; Postpartum exclusion criteria 1. Mothers develop health complications after birth, such as acute uterine inversion, post partum hemorrhage or post partum depression; 2. Infants are admitted to the neonatal intensive care unit, or 1-minute Apgar score< 6, 5-minute Apgar score < 6, had low birth weight (<2500 g), or were born prematurely (<37 weeks of gestation); 3. Infants are diagnosed cleft palate or other congenital abnormality that will prohibit breastfeeding; 4. Mothers and infants move out or not live in Huzhu County are after birth. 5. With illness that limited breastfeeding after childbirth. 6. Plan to go out in the future longer than one year; 7. Plan to change mobile phone number within one year. 

研究实施时间:

Study execute time:

From2018-10-01To 2019-10-01 

干预措施:

Interventions:

组别:

干预组

样本量:

200

Group:

Intervention group

Sample size:

干预措施:

微信健康教育

干预措施代码:

Intervention:

Wechat health education

Intervention code:

组别:

对照组

样本量:

200

Group:

Control group

Sample size:

干预措施:

常规保健服务

干预措施代码:

Intervention:

Routine health care services

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

青海 

市(区县):

海东市 

Country:

China 

Province:

Qinghai 

City:

Haidong 

单位(医院):

互助妇幼保健院 

单位级别:

 

Institution
hospital:

Huzhu Maternal and Child health hospital  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

纯母乳喂养率

指标类型:

主要指标 

Outcome:

Exclusive breastfeeding rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

纯母乳喂养时间

指标类型:

主要指标 

Outcome:

Duration of exclusive breastfeeding

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

母乳喂养时间

指标类型:

主要指标 

Outcome:

Duration of breastfeeding

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

早开奶率

指标类型:

次要指标 

Outcome:

Early initiation of breastfeeding rate

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 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):

由不涉及数据收集的工作人员用计算机生成400个随机数字,取所有随机数字的中位数(196)作为临界值,小于或等于中位数的随机数字为干预组,大于中位数的随机数字为对照组,将所有的随机数字和分组打印在小卡片上并分别放入不透明的信封中。

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

An independent researcher who will not participate in participant recruitment or data collection generated 400 random numbers using Micro Excel. She used the median (196) as threshold, random number that less than or equals to the median were allocated as the intervention group, while the random number that

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

wuqiong063@126.com

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

wuqiong063@126.com

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-07-26
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