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BreastfeedingNCT05851651

Gestational Diabetes and Antenatal Human Milk Expression

A study testing Antenatal milk expression and breastfeeding self-efficacy enhancement in people with Breastfeeding, run by The University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breastfeeding
What is being tested?
Antenatal milk expression and breastfeeding self-efficacy enhancement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
2 sitesHong Kong
Study dates
10 May 2023to 10 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • singleton pregnancy
  • primiparous or multiparous women
  • intention to breastfeed
  • pre-pregnancy BMI<25

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites
  • Kwong Wah Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Conditions
Breastfeeding
Being tested
Antenatal milk expression and breastfeeding self-efficacy enhancement
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antenatal milk expression and breastfeeding self-efficacy enhancementBehavioural

    A face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation will be arranged. The session will approximately last for 45minutes. GDM leaflet and GAME fact sheet are used to facilitate the teaching. The benefits of breastfeeding for women with GDM will be addressed. Maternal metabolic control, calories consumed, and weight loss are addressed for the extra benefits of breastfeeding for GDM women. The possible challenges of GDM on breastfeeding will be supported. The antenatal human milk expression will be taught by International Board-Certified Lactation Consultant. Participants will be encouraged to express colostrum twice daily for up to 10 minutes until admitted to hospital to give birth. They will receive a weekly phone follows up from 38 weeks before delivery and they can contact the researcher by phone in the information sheet if any questions.

Study groups in NCT05851651
Study groupRoleWhat they receive
Standard care plus an antenatal milk expression educationExperimentalParticipants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery.
Receives: Behavioral: Antenatal milk expression and breastfeeding self-efficacy enhancement
Standard hospital antenatal careNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant Feeding pattern

    Exclusive breastfeeding prevalence

    Measured: At 4 weeks postpartum

  2. Infant Feeding pattern

    Exclusive breastfeeding prevalence

    Measured: At 8 weeks postpartum

Secondary outcomes (4)
  1. Women's self-determination toward breastfeeding

    Chinese Breastfeeding Self -Regulation Questionnaire is a 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.

    Measured: At baseline, 4 weeks and 8 weeks postpartum

  2. Women's self-efficacy in breastfeeding

    Breastfeeding Self-Efficacy Scale-Short Form is used to measure maternal breastfeed confidence during postpartum. 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 14 items. The scale is psychometrically tested, demonstrates a consistent high reliability and validity. Low breastfeeding self- efficacy is significant predictor of early attrition of breastfeeding.

    Measured: At baseline, 4 weeks and 8 weeks postpartum

  3. Women's perinatal/postnatal depression

    Edinburgh Perinatal/Postnatal Depression Scale is used during antepartum and postpartum. 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 psychometrically tested, high reliability and validity for perinatal and at 6 weeks postpartum. Successful breastfeeding is predictive of lower maternal depressive symptomology.

    Measured: At baseline, 4 weeks and 8 weeks postpartum

  4. Women's prevalence of Impaired Glucose Tolerance

    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.

    Measured: At 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start10 May 2023
  3. Primary completion10 May 2024
  4. Study completion10 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05851651
Sponsor's protocol ID
GAME
Status last verified
Apr 2023
First submitted
17 Apr 2023
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leung YN, Chau PH, Dai Y, Lam CCO, Leung WC, Lok KYW. The Gestational Diabetes Antenatal Milk Expression (GAME) trial: effects on breastfeeding outcomes and maternal mental health-A randomised controlled trial. EClinicalMedicine. 2026 Aug 5;98:104130. doi: 10.1016/j.eclinm.2026.104130. eCollection 2026 Aug.

    PubMed 42592109

Questions about this trial

What is this clinical trial studying?

A study testing Antenatal milk expression and breastfeeding self-efficacy enhancement in people with Breastfeeding, run by The University of Hong Kong at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Feeding pattern (time frame: At 4 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05851651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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