A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 4
- 主要终点
- Prevalence of any and exclusive breastfeeding
研究概览
简要总结
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.
详细描述
The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.
The primary hypotheses are:
- Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
- The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
The secondary hypotheses are:
- The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
- The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •delivers at participating trial site,
- •primiparous,
- •intends to breastfeed,
- •18 years of age or older,
- •has singleton pregnancy,
- •Cantonese speaking,
- •Hong Kong resident for more than one year,
- •no serious medical or obstetrical complications
排除标准
- •< 37 weeks gestation,
- •an Apgar score < 8 at five minutes,
- •a birth weight < 2500 grams,
- •born with any severe medical conditions or congenital malformations,
- •is placed in the special care nursery for more than 48 hours after delivery,
- •is placed in the intensive care nursery after delivery,
- •not entitled to health benefits in Hong Kong (NEP).
研究组 & 干预措施
Control
In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team.
In-hospital professional support
The participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization.
干预措施: In-hospital professional support (Other)
Postpartum telephone follow-up support
Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.
干预措施: Postpartum telephone follow-up support (Other)
结局指标
主要结局
Prevalence of any and exclusive breastfeeding
时间窗: 3 months postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
Prevalence of any and exclusive breastfeeding
时间窗: 1 month postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
Prevalence of any and exclusive breastfeeding
时间窗: 2 months postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
次要结局
- Median duration of breastfeeding(6 month postpartum)
研究者
Marie Tarrant
Associate Professor
The University of Hong Kong