The Gestational Diabetes Antenatal Milk Expression (GAME) trial: effects on breastfeeding outcomes and maternal mental health-A randomised controlled trial.

Abstract

Women with Gestational Diabetes Mellitus (GDM) are at increased risk of delayed lactogenesis and suboptimal breastfeeding. Although antenatal milk expression (AME) may facilitate lactation, its safety and efficacy in this population are not established. We aimed to evaluate the effects of a structured AME programme on breastfeeding and maternal psychosocial outcomes in women with GDM. We conducted a two-centre, parallel-group, assessor-blinded, randomised controlled trial at two public antenatal clinics in Hong Kong from May 10, 2023, to May 10, 2024. Two hundred and fourty-six pregnant women with singleton pregnancy and diagnosis of GDM at 34-36 weeks' gestation were randomly assigned (1:1) to receive the Gestational Diabetes and Antenatal Milk Expression (GAME) intervention, comprising education and support, or standard care. The primary outcome was exclusive breastfeeding across the postpartum period assessed at three timepoints: hospital discharge, four weeks postpartum, and eight weeks postpartum. Secondary outcomes included maternal depressive symptoms, breastfeeding self-efficacy, and breastfeeding self-regulation. Analysis was by intention-to-treat using Generalised Linear Mixed Models. This trial is registered with ClinicalTrials.gov, NCT05851651. Over the 8-week postpartum period, the proportion of women exclusively breastfeeding in the intervention group was higher than in control group at discharge (16.3% vs. 8.9%; aOR 2.28 [95% CI 1.01-5.14]), four weeks (30.9% vs. 20.3%; aOR 2.00 [1.07-3.74]), and eight weeks (29.3% vs. 25.2%; aOR 1.37 [0.73-2.56]). The intervention group demonstrated significantly higher odds of exclusive breastfeeding over time (adjusted odds ratio 2.43 [95% CI 1.17-5.04], p < 0.05). Regarding secondary outcomes, the intervention group reported significantly lower maternal depressive symptoms at 8 weeks postpartum (mean difference -1.74 [95% CI -2.94 to -0.54], p = 0.004) and higher breastfeeding self-efficacy at 8 weeks postpartum (mean difference 3.30 [95% CI 0.12-6.48], p = 0.042). Rates of any breastfeeding did not differ significantly between groups at any time point (aOR 0.68 [95% CI 0.21-2.20]). Neonatal hypoglycaemia and gestational age at birth did not differ between groups. The GAME programme significantly increased exclusive breastfeeding, improved breastfeeding self-efficacy, and reduced maternal depressive symptoms in women with GDM, with no added perinatal risk. Integrating structured AME into routine antenatal care could improve both infant feeding and maternal psychological well-being in this high-risk population. Kowloon Central Cluster Research Grant (KCC/RG/G/2223-A02), Hospital Authority and Seed Funding for Basic Research (2202100786) at The University of Hong Kong.