Evaluation of the Effectiveness of Osteopathic Treatment on the Mother-newborn Dyad in the Event of Painful Breastfeeding in the Maternity Hospital Despite the Application of All Usual Aids: Randomized Interventional Study in Clusters in Two Parallel Arms Without Blinding. AMATOSTEO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Proportion of women still breastfeeding
研究概览
简要总结
Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. The aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. The primary outcome is the lactation rate (exclusive or partial) at 1 month after birth
详细描述
Breastfeeding is recognized to be essential for childhood health and public health. The first reason to stop breastfeeding before the second month after birth is pain during lactation. The second reason to stop breastfeeding is back-to-work, generally two months after birth. Few years ago, osteopathic treatment has been introduced at maternity hospital of Bordeaux when usual known aids are ineffective. The osteopathic treatment is completely integrated in the maternity hospital of Bordeaux but no strong evaluation is available in literature. A pilot evaluation on 27 patients showed a good effectiveness of osteopathic treatment on breastfeeding at 1 months ½ after birth (85% of patients) Breast pain decreased or disappeared after the osteopathic treatment. Another evaluation showed a small rate of lactation (15% of patients) in a non treated group at 1 month ½. In the present study, osteopathic treatment will be added to usual known aids for 40 mother-newborn dyads when pain during lactation is greater than 7 (0 to 10 scale). The experimental group will be compared with 40 "non treated" mother-newborn dyads (only usual known aids in routine care). Among other, breastfeeding and pain during lactation will be evaluated at the maternity hospital discharge and will be repeated at 1 month after birth.
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
- 3 Days 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mother 18 yrs and older who chose to breast-feed (exclusive or not)
- •Singleton newborn after 37 weeks of gestation, weighing at least 2500 g at birth, after 36 hours of life
- •Pain during lactation greater than 7 (scale 0 to 10) in one or both breasts
- •Usual known aids ineffective to reduce pain during lactation
- •Mother speaking and understanding French
- •Mother affiliated or beneficiary to a health system
- •Signed informed consent.
排除标准
- •Medical contraindication to osteopathic treatment (non stabilized infection, acute neurological pathology, tumor or cancer process, maternal psychiatric disorders)
- •Severe congenitale malformation, especially not allowing normal lactation
- •Patient under legal protection
- •Persons deprived of their liberty by judicial or administrative decision
结局指标
主要结局
Proportion of women still breastfeeding
时间窗: 1 month after birth
Proportion of women still breastfeeding even if not exclusive
次要结局
- Proportion of women still exclusive breastfeeding(1 month)
- Pain during lactation(7 days, 1 month)
- breastfeeding(7 days, 1 month)
- Amount of artificial milk given per day(1 month)