Enhancing breastfeeding outcomes in postpartum women with insufficient breast milk supply: protocol for a six-month longitudinal randomized trial of self-administered acupressure

改善产后母乳不足妇女的母乳喂养效果:一项为期六个月的自我穴位按摩纵向随机试验方案

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Abstract

BACKGROUND: Insufficient breast milk supply (IBMS) is a critical challenge to achieving optimal breastfeeding outcomes worldwide. While Traditional Chinese Medicine (TCM)-based acupressure has demonstrated promise for lactation, its clinical effectiveness remains insufficiently explored. This study aims to investigate the effectiveness of self-administered acupressure (SAA) as a non-pharmacological intervention for IBMS and its longitudinal effects on breastfeeding outcomes. METHODS: This six-month randomized controlled trial (RCT) will enroll 184 postpartum women experiencing IBMS from the Department of Obstetrics at West China Second University Hospital. Participants will be randomly assigned to either an intervention group receiving daily SAA targeting three acupoints (Danzhong, Rugen, and Shaoze) performed 3 times per day for 10-15 min each session, or a control group receiving routine postpartum care. The primary outcome is the exclusive breastfeeding rate. Secondary outcomes include mother-infant attachment, postpartum depression, breastfeeding self-efficacy, infant feeding attitude, and maternal parenting confidence. Outcome assessments will be conducted at hospital discharge, and at 14 days, 42 days, 3 months, and 6 months postpartum. In addition, breast milk samples will be collected from 30 participants in each group at 14 days postpartum to analyze lactation-related hormonal biomarkers. DISCUSSION: This trial will provide high-quality evidence on the clinical utility of SAA in managing IBMS and enhancing breastfeeding outcomes over time. By integrating psychosocial assessments with hormonal analysis, the study aims to inform the development of safe, accessible, and culturally appropriate lactation support strategies, particularly in low-resource settings. Findings may contribute to the advancement of personalized, non-invasive interventions to support sustained breastfeeding. TRIAL REGISTRATION: This study has been registered at Chinese Clinical Trial Registry (registration number: ChiCTR2500097270) on 17 February, 2025, and has been updated once.

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