Early and Regular Breast Milk Expression to Help Establish Lactation After Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Successful initiation of lactation as determined by lactogenesis II markers.
研究概览
简要总结
The purpose of this study is to determine whether early start of either breastfeeding or breast milk expression may positively affect milk production later in lactation.
120 breastfeeding mothers will be recruited and randomized into 4 groups (2 groups with preterm deliveries) and 2 groups with term deliveries. One group will be given a breast pump to pump early and regularly. the second group will be encouraged to breastfeed in response to baby's cues. Breast milk samples will be collected at the end of a week.
详细描述
The initiation of lactation in women depends on the growth of the glandular tissue of the breast (mammogenesis) and the differentiation of the mammary secretory epithelial cells (lactocytes) during pregnancy (lactogenesis I). After birth, the continuous nourishment of the fetus from the mother via the umbilical cord is replaced by the equally important but intermittent nourishment from the mother's breast. The onset of copious milk production (lactogenesis II) is closely coupled to the factors controlling the birth process. In mothers who have delivered pre-term, mammogenesis and lactogenesis I may be truncated and close consideration must be given to all physiological aspects of this complex process when assisting preterm mothers to establish successful lactation. In Singapore, the problem is not restricted to mothers of preterm babies. In a nation-wide survey by the Health Promotion Board in 2001, inability to produce enough breast milk was stated as the reason for not breastfeeding by 53% of mothers two months after birth.
The hypothesis of this study is that early, regular and complete emptying of the breasts can hasten and improve the establishment of lactogenesis II after preterm and term deliveries.
It aims to compare the effect of early and regular breast milk expression on the success and timing of establishment of lactogenesis II compared with routine breastfeeding practice in mothers after preterm and term deliveries.
The second aim is to study the effect of early and regular breast milk expression on blood prolactin and progesterone levels in women after preterm and term deliveries.
The final aim is to study the volume of breast milk produced and fed to babies after preterm and term deliveries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •60 women with preterm pregnancies who want to breastfeed their babies will be recruited and 60 women with term pregnancies who want to breastfeed their babies will be recruited and randomized.
排除标准
- •Those with maternal diabetes and hyperprolactinaemia, as well as fetal congenital anomalies and multiple pregnancies will be excluded.
研究组 & 干预措施
D
A
Breast pump given and used on regular intervals
干预措施: Early and regular breast milk expression (Procedure)
B
c
Breast pump given to be used on regular interval
干预措施: Early and regular breast milk expression (Procedure)
结局指标
主要结局
Successful initiation of lactation as determined by lactogenesis II markers.
时间窗: 7 days postpartum
Successful initiation of lactation as determined by maternal perception.
时间窗: 7 days postpartum
次要结局
- Volume of colostrum and milk expressed, and fed to the neonate(7 days postpartum)
- Weight change in baby 7 days after birth. Statistical considerations(7 days postpartum)