Gestational Diabetes and Antenatal Human Milk Expression
- Conditions
- Breastfeeding
- Interventions
- Behavioral: Antenatal milk expression and breastfeeding self-efficacy enhancement
- Registration Number
- NCT05851651
- Lead Sponsor
- The University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 244
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care plus an antenatal milk expression education Antenatal milk expression and breastfeeding self-efficacy enhancement Participants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery.
- Primary Outcome Measures
Name Time Method Infant Feeding pattern At 8 weeks postpartum Exclusive breastfeeding prevalence
- Secondary Outcome Measures
Name Time Method Women's perinatal/postnatal depression At baseline, 4 weeks and 8 weeks postpartum 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.
Women's prevalence of Impaired Glucose Tolerance At 6 weeks postpartum 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.
Women's self-efficacy in breastfeeding At baseline, 4 weeks and 8 weeks postpartum 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.
Women's self-determination toward breastfeeding At baseline, 4 weeks and 8 weeks postpartum 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.
Trial Locations
- Locations (2)
Kwong Wah Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Elizabeth Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong