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【ChiCTR2400085296】Gestational Diabetes and Antenatal Human Milk Expression

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基本信息

登记号

ChiCTR2400085296

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2024-06-04

临床申请受理号

靶点

适应症

Gestational Diabetes

试验通俗题目

Gestational Diabetes and Antenatal Human Milk Expression

试验专业题目

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

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

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.

试验分类

试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

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

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.

试验项目经费来源

This research did not receive any funding.

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-07-01

试验终止时间

2022-07-01

是否属于一致性

入选标准

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；

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；

研究者信息

研究负责人姓名

试验机构

The University of Hong Kong

研究负责人电话

研究负责人邮箱

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联系人通讯地址

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