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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Gestational Diabetes and Antenatal Human Milk Expression

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注册号：

Registration number：

ChiCTR2400085296 

最近更新日期：

Date of Last Refreshed on：

2024-06-04 17:36:18 

注册时间：

Date of Registration：

2024-06-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Gestational Diabetes and Antenatal Human Milk Expression

Public title：

Gestational Diabetes and Antenatal Human Milk Expression

注册题目简写：

GAME

English Acronym：

GAME

研究课题的正式科学名称：

The Effects and Experience of a Gestational Diabetes and Antenatal Human Milk Expression (GAME) Programme in Hong Kong Chinese Women

Scientific title：

The Effects and Experience of a Gestational Diabetes and Antenatal Human Milk Expression (GAME) Programme in Hong Kong Chinese Women

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：

Kris YW Lok 

研究负责人：

Leung Yu Ngai 

Applicant：

Kris YW Lok 

Study leader：

Leung Yu Ngai 

申请注册联系人电话：

Applicant telephone：

+852 3917 6690

研究负责人电话：

Study leader's telephone：

+852 2332 2311

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：

krislok@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

leungyn@ha.org.hk

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：

School of Nursing, the University of Hong Kong 5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong

研究负责人通讯地址：

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

Applicant address：

School of Nursing, the University of Hong Kong 5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong

Study leader's address：

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

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：

The University of Hong Kong

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

Affiliation of the Leader：

Department of Obstetrics & Gynaecology, Kwong Wah Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KC/KE-21-0119/ER-1

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：

Research Ethics Committee (Kowloon Central/ Kowloon East)

Name of the ethic committee：

Research Ethics Committee (Kowloon Central/ Kowloon East)

伦理委员会批准日期：

Date of approved by ethic committee：

2021-07-12 00:00:00

伦理委员会联系人：

Dr Eric CHEUNG

Contact Name of the ethic committee：

Dr Eric CHEUNG

伦理委员会联系地址：

Queen Elizabeth Hospital, 30 Gascoigne Road Kowloon

Contact Address of the ethic committee：

Queen Elizabeth Hospital, 30 Gascoigne Road Kowloon

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3506 8888

伦理委员会联系人邮箱：

Contact email of the ethic committee：

qeh_webmaster@ha.org.hk

研究实施负责（组长）单位：

The University of Hong Kong

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

The University of Hong Kong, Pokfulam, Hong Kong

Primary sponsor's address：

The University of Hong Kong, Pokfulam, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Hong Kong SAR

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong SAR

单位(医院)：

The University of Hong Kong

具体地址：

The University of Hong Kong, Pokfulam, Hong Kong

Institution
hospital：

The University of Hong Kong

Address：

The University of Hong Kong, Pokfulam, Hong Kong

经费或物资来源：

This research did not receive any funding.

Source(s) of funding：

This research did not receive any funding.

Target disease：

Gestational Diabetes

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Exclusive breastfeeding is global recognized as the optimal infant feeding. Hong Kong is committed to promoting, protecting, and supporting the global movement for successful breastfeeding. Exclusive breastfeeding is especially strongly recommended and supported to the maternal history of Gestational Diabetes Mellitus (GDM). This study aims to examine the acceptability and feasibility of Antenatal human milk expression (AME) as breastfeeding intervention to improve breastfeeding for GDM women. The efficacy of AME practice on the breastfeeding exclusivity will also be investigated. It is hypothesized that AME will increase breastfeeding exclusivity compare with women receiving standard care, and will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.  

Objectives of Study：

Exclusive breastfeeding is global recognized as the optimal infant feeding. Hong Kong is committed to promoting, protecting, and supporting the global movement for successful breastfeeding. Exclusive breastfeeding is especially strongly recommended and supported to the maternal history of Gestational Diabetes Mellitus (GDM). This study aims to examine the acceptability and feasibility of Antenatal human milk expression (AME) as breastfeeding intervention to improve breastfeeding for GDM women. The efficacy of AME practice on the breastfeeding exclusivity will also be investigated. It is hypothesized that AME will increase breastfeeding exclusivity compare with women receiving standard care, and will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Diagnosed gestational diabetes without on insulin 2. aged 18 years or above 3. Can read and speak Chinese 4. Hong Kong resident and stay in Hong Kong after delivery 5. No serious medical or obstetrical complications 6. No mental health illness or history 7. Have regular antenatal check-up 8. Singleton pregnancy 9. Primiparous or multiparous women 10. Intention to breastfeed 11. Pre-pregnancy BMI<25

Inclusion criteria

1. Diagnosed gestational diabetes without on insulin 2. aged 18 years or above 3. Can read and speak Chinese 4. Hong Kong resident and stay in Hong Kong after delivery 5. No serious medical or obstetrical complications 6. No mental health illness or history 7. Have regular antenatal check-up 8. Singleton pregnancy 9. Primiparous or multiparous women 10. Intention to breastfeed 11. Pre-pregnancy BMI<25

排除标准：

1. Do not have Hong Kong Identify Card 2. Breastfeeding elder child at pregnancy 3. Cannot understand the study 4. Give birth <37 weeks of gestation 5. A known fetal anomaly or any suspicion of fetal compromise

Exclusion criteria：

1. Do not have Hong Kong Identify Card 2. Breastfeeding elder child at pregnancy 3. Cannot understand the study 4. Give birth <37 weeks of gestation 5. A known fetal anomaly or any suspicion of fetal compromise

研究实施时间：

Study execute time：

从 From 2021-07-01 00:00:00至 To 2022-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-09-08 00:00:00 至 To 2021-12-31 00:00:00  

干预措施：

Interventions：

组别：

Experimental: Standard care plus an antenatal milk expression education

样本量：

10

Group：

Experimental: Standard care plus an antenatal milk expression education

Sample size：

干预措施：

Participants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery.

干预措施代码：

Intervention：

Participants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery.

Intervention code：

组别：

No Intervention: Standard hospital antenatal care

样本量：

10

Group：

No Intervention: Standard hospital antenatal care

Sample size：

干预措施：

Participants will receive standard care include prenatal breastfeeding education at gestation of 24-36 weeks same as intervention group. They will not discuss about antenatal milk expression, breastfeeding self-efficacy and the effects of breastfeeding on GDM women.

干预措施代码：

Intervention：

Participants will receive standard care include prenatal breastfeeding education at gestation of 24-36 weeks same as intervention group. They will not discuss about antenatal milk expression, breastfeeding self-efficacy and the effects of breastfeeding on GDM women.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

 Hong Kong SAR 

Country：

China 

Province：

Hong Kong SAR 

City：

Hong Kong SAR 

单位(医院)：

The University of Hong Kong 

单位级别：

University 

Institution
hospital：

The University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Exclusive breastfeeding prevalence

指标类型：

主要指标

Outcome：

Exclusive breastfeeding prevalence

Type：

Primary indicator

测量时间点：

At 4 weeks and 8 weeks postpartum

测量方法：

The infant feeding pattern will be assessed at 4 and 8 weeks postpartum by telephone follow-up regarding to group allocation by research assistant. The research assistant was blinded for the allocation of the intervention and control group. If women stop breastfeeding, the breastfeeding duration will be measured as the numbers of days of breastfeeding.

Measure time point of outcome：

At 4 weeks and 8 weeks postpartum

Measure method：

The infant feeding pattern will be assessed at 4 and 8 weeks postpartum by telephone follow-up regarding to group allocation by research assistant. The research assistant was blinded for the allocation of the intervention and control group. If women stop breastfeeding, the breastfeeding duration will be measured as the numbers of days of breastfeeding.

指标中文名：

Women's self-determination toward breastfeeding

指标类型：

次要指标

Outcome：

Women's self-determination toward breastfeeding

Type：

Secondary indicator

测量时间点：

At 4 weeks and 8 weeks postpartum

测量方法：

Examine Breastfeeding Self -Regulation Questionnaire (BSRQ). The Chinese version of the BSRQ was psychometric tested valid and reliable tool to measure maternal self-determination towards breastfeeding. The Cronbach's alpha of the BSRQ was 0.86. For every one-point increase in the BSRQ score, participants had 15% higher odds of any breastfeeding (OR=1.15, 95%CI 1.07–1.23) and 9% higher odds of exclusive breastfeeding (OR=1.09, 95%CI 1.02–1.17) at 6 weeks postpartum.

Measure time point of outcome：

At 4 weeks and 8 weeks postpartum

Measure method：

Examine Breastfeeding Self -Regulation Questionnaire (BSRQ). The Chinese version of the BSRQ was psychometric tested valid and reliable tool to measure maternal self-determination towards breastfeeding. The Cronbach's alpha of the BSRQ was 0.86. For every one-point increase in the BSRQ score, participants had 15% higher odds of any breastfeeding (OR=1.15, 95%CI 1.07–1.23) and 9% higher odds of exclusive breastfeeding (OR=1.09, 95%CI 1.02–1.17) at 6 weeks postpartum.

指标中文名：

Women's self-efficacy in breastfeeding

指标类型：

次要指标

Outcome：

Women's self-efficacy in breastfeeding

Type：

Secondary indicator

测量时间点：

At 4 weeks and 8 weeks postpartum

测量方法：

Measure Breastfeeding Self-Efficacy Scale–Short Form (BSES-SF) when subjects recruit by the questionnaire, at 4 week and at 8 weeks postpartum when woman is breastfeeding using semi-structured questionnaire by phone interview or via Web-based questionnaires. BSES-SF is used to measure maternal breastfeed confidence during postpartum.60,73 This instrument consists of 14 items, ranging from 1 = 'Not at all confident' to 5= 'Very confident.' The summary score from 14 to 70 is created by adding 1

Measure time point of outcome：

At 4 weeks and 8 weeks postpartum

Measure method：

Measure Breastfeeding Self-Efficacy Scale–Short Form (BSES-SF) when subjects recruit by the questionnaire, at 4 week and at 8 weeks postpartum when woman is breastfeeding using semi-structured questionnaire by phone interview or via Web-based questionnaires. BSES-SF is used to measure maternal breastfeed confidence during postpartum.60,73 This instrument consists of 14 items, ranging from 1 = 'Not at all confident' to 5= 'Very confident.' The summary score from 14 to 70 is created by adding 1

指标中文名：

Women's perinatal/postnatal depression

指标类型：

次要指标

Outcome：

Women's perinatal/postnatal depression

Type：

Secondary indicator

测量时间点：

At 4 weeks and 8 weeks postpartum

测量方法：

Measure Edinburgh Perinatal/Postnatal Depression Scale (EPDS) during antepartum and postpartum.76-77 It consist of 10 items include anxiety and depressive and symptoms; cut-off point is 9/10. It has a sensitivity of 0.86 and specificity of 0.78 with a positive predictive value of 73%. It was translated in Hong Kong Chinese. It psychometrically tested, high reliability and validity for perinatal and at 6 weeks postpartum.77-78 It will be collected at baseline, on discharge and at 8 weeks postp

Measure time point of outcome：

At 4 weeks and 8 weeks postpartum

Measure method：

Measure Edinburgh Perinatal/Postnatal Depression Scale (EPDS) during antepartum and postpartum.76-77 It consist of 10 items include anxiety and depressive and symptoms; cut-off point is 9/10. It has a sensitivity of 0.86 and specificity of 0.78 with a positive predictive value of 73%. It was translated in Hong Kong Chinese. It psychometrically tested, high reliability and validity for perinatal and at 6 weeks postpartum.77-78 It will be collected at baseline, on discharge and at 8 weeks postp

指标中文名：

Women's prevalence of Impaired Glucose Tolerance

指标类型：

次要指标

Outcome：

Women's prevalence of Impaired Glucose Tolerance

Type：

Secondary indicator

测量时间点：

At 6 weeks postpartum

测量方法：

Prevalence of IGT among participants according to breastfeeding status (any breastfeeding or exclusive formula feeding) will be collected from medical record for the fasting blood sugar testing at 6 weeks postpartum.

Measure time point of outcome：

At 6 weeks postpartum

Measure method：

Prevalence of IGT among participants according to breastfeeding status (any breastfeeding or exclusive formula feeding) will be collected from medical record for the fasting blood sugar testing at 6 weeks postpartum.

指标中文名：

Women's experience, perception, and attitude for AME practices

指标类型：

次要指标

Outcome：

Women's experience, perception, and attitude for AME practices

Type：

Secondary indicator

测量时间点：

At 6 weeks postpartum

测量方法：

Those participants response the highest and lowest self-efficacy score at baseline and 4 weeks postpartum will be invited to join the interview. The interview will last approximately 60-90 minutes.

Measure time point of outcome：

At 6 weeks postpartum

Measure method：

Those participants response the highest and lowest self-efficacy score at baseline and 4 weeks postpartum will be invited to join the interview. The interview will last approximately 60-90 minutes.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age N/A 岁 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）：

A computerized random numbers and block sizes of four or six distributed randomly from the Research Randomizer software will be generated.

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

A computerized random numbers and block sizes of four or six distributed randomly from the Research Randomizer software will be generated.

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：

Single blinded with masked the participants for group allocation and outcome assessor is masked to blocked size and allocation. The investigators deliver the intervention and analysing the data is not blinded.

Blinding：

Single blinded with masked the participants for group allocation and outcome assessor is masked to blocked size and allocation. The investigators deliver the intervention and analysing the data is not blinded.

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

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）：

IISupreme (https://iis-ctc.hku.hk/)

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

IISupreme (https://iis-ctc.hku.hk/)

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：

Data collection will consist of data collected from participants’ medical record and directly from participants while visiting obstetric outpatient setting or breastfeeding clinic after their GDM diagnosis and by telephone in the postpartum period.

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

Data collection will consist of data collected from participants’ medical record and directly from participants while visiting obstetric outpatient setting or breastfeeding clinic after their GDM diagnosis and by telephone in the postpartum period.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-06-04 17:36:13
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