Prospective Randomized Controlled Clinical Trial on the Impact of Antepartum Breast Milk Expression on Breastfeeding Rates in Patients With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 主要终点
- Exclusive breastfeeding rates at 3 months postpartum
研究概览
简要总结
This study proposes a prospective randomized controlled clinical trial involving primiparous women diagnosed with gestational diabetes mellitus (GDM) carrying singleton pregnancies. Participants will be randomized in a 1:1 ratio into either a control group or an intervention group.
The control group will receive standard prenatal care followed by routine postpartum breastfeeding guidance.
In addition to the standard care provided to the control group, the intervention group will receive one-on-one midwife-led manual breast milk expression training at the breastfeeding clinic. They will begin manual expression twice daily starting at 37 weeks gestation.
The primary outcome will compare exclusive breastfeeding rates at 3 months postpartum between groups through postpartum follow-up assessments to evaluate the impact of antenatal milk expression on breastfeeding success in GDM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Expressed intention for exclusive breastfeeding; Aged 20-45 years; Nulliparous status; Singleton pregnancy; GDM diagnosed per 75g OGTT at 24-28 weeks
排除标准
- •Contraindications to breastfeeding; multifetal pregnancy; placenta previa; pregestational diabetes mellitus; preeclampsia; contraindications to vaginal delivery; fetal structural anomalies (cleft lip/palate, cardiac malformations, neural tube defects); chromosomal abnormalities or metabolic disorders affecting suckling ability (e.g., phenylketonuria); intrauterine growth restriction; macrosomia; polyhydramnios; maternal psychiatric disorders (depression or anxiety disorders)
研究组 & 干预措施
Antepartum Milk Expression Group
Oarticipants will receive one-on-one antenatal breast milk expression instruction by a midwife and initiate twice-daily practice from 37 weeks gestation onward.
干预措施: milk expression (Procedure)
Control group
Participants will receive routine antenatal care and standard postpartum management
结局指标
主要结局
Exclusive breastfeeding rates at 3 months postpartum
时间窗: 3 months postpartum
次要结局
未报告次要终点