Clinical trial NCT05851651: Gestational Diabetes and Antenatal Human Milk Expression
Official title: The Effects and Experience of a Gestational Diabetes and Antenatal Human Milk Expression (GAME) Programme in Hong Kong Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The incidence of GDM has been increasing worldwide and varied globally. Women with previous GDM have a 7-fold higher risk of developing diabetes mellitus over their lifetime. It has emerged global public health concern. Studies found that women with GDM breastfeed her baby significantly reduce the risk of Type 2 Diabetes and cardiometabolic disease, and improve postpartum glucose metabolism. However, evidence shows that GDM women have breastfeeding challenges and barriers. Women with diabetes experience delay in lactogenesis and infant have increased risk hypoglycaemia, they require blood monitoring and are often admit to the neonatal unit. As a result, the infants are more likely to have early receiving of formula supplementation. Besides, evidence indicated that low maternal confidence, increase depressive symptoms and breastfeeding self-efficacy among GDM women. Therefore, early lactation support was necessary. Greater support for GDM women reduces the risks of hypoglycaemia, formula supplementation and early weaning. It has been proposed that hand expression of breast milk in pregnancy may promote breastfeeding. Mothers with diabetes can express colostrum antenatally for use rather than infant formula if necessary.

Though Antenatal Milk Expression (AME) advises women at risk of early lactation problems, very limited evidence regarding the safety and efficacy of the practice. Also, very limited evidence investigated the AME for diabetes women for improving infant outcomes. Few studies found that AME increased confidence and contributed to better preparation on breastfeeding, but AME on depressive symptoms is under examined.

In Hong Kong, AME is not widely practice with inconsistent advice. It may raise concern on culture diversity regarding conservative culture in Chinese. There is lack of local article on the feasibility and acceptability of AME practice for GDM women in Hong Kong. Local clinical protocol on the implementation of AME and instructions on the practice is also absent. Given cultural differences in breastfeeding motivation and self-regulation as compared with those of oversea countries, the motivation of Hong Kong pregnant women engages in antenatal education and receiving social and breastfeeding support may be differ from women in the West. Thus, it is important to evaluate the efficacy and experience of AME on Hong Kong Chinese to assess cultural acceptability and effectiveness in supporting baby-friendly hospital practice and breastfeeding continuation.

Limited qualitative study compares breastfeeding self-efficacy on GDM women and positive impacts of the self-efficacy on breastfeeding prevalence and duration. Besides, qualitative study on the experiences and perceptions of GDM women on breastfeeding, and the experience on the collection and storage of expressed colostrum are very rare.

This blocked randomized, parallel-armed controlled trial with mixed method study design which integrating with quantitative and qualitative study will be conducted to examine (1) the acceptability and feasibility of AME as breastfeeding intervention to improve breastfeeding for GDM women, how and why AME works or does not work using qualitative research; (2) to understand the experience and perceptions of antenatal milk expression among the GDM women and (3) to investigate the efficacy of AME practice on the breastfeeding exclusivity. The secondary aims are determining whether AME as mediating variables in the effect on the breastfeeding self-efficacy among Hong Kong GDM women in Hong Kong.

The study hypotheses are (1) Antenatal human milk expression (AME) will increase breastfeeding exclusivity on hospital discharge, at 4 weeks and 8 weeks postpartum compare women receiving standard care (2) AME will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.

Eligibility criteria: Inclusion Criteria:

* diagnosed gestational diabetes without on insulin
* can read and speak Chinese
* Hong Kong resident and stay in Hong Kong after delivery
* no serious medical or obstetrical complications
* no mental health illness or history
* have regular antenatal check-up
* singleton pregnancy
* primiparous or multiparous women
* intention to breastfeed
* pre-pregnancy BMI\<25

Exclusion Criteria:

* do not have Hong Kong Identify Card
* breastfeeding elder child at pregnancy
* cannot understand the study
* give birth \<37 weeks of gestation
* a known fetal anomaly or any suspicion of fetal compromise

Primary outcomes:
measure: Infant Feeding pattern
timeFrame: At 4 weeks postpartum
measure: Infant Feeding pattern
timeFrame: At 8 weeks postpartum
Secondary outcomes:
measure: Women's self-determination toward breastfeeding
timeFrame: At baseline, 4 weeks and 8 weeks postpartum
measure: Women's self-efficacy in breastfeeding
timeFrame: At baseline, 4 weeks and 8 weeks postpartum
measure: Women's perinatal/postnatal depression
timeFrame: At baseline, 4 weeks and 8 weeks postpartum
measure: Women's prevalence of Impaired Glucose Tolerance
timeFrame: At 6 weeks postpartum
Other outcomes:
measure: Women's experience, perception, and attitude for AME practices
timeFrame: At 6 weeks postpartum
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Kwong Wah Hospital
name: Yu Ngai Ms Leung, MPH
role: PRINCIPAL_INVESTIGATOR
References: