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临床试验/NCT03875794
NCT03875794终止不适用

OMILQ: Osteopathic Manipulation to Increase Lactation Quantity (OMILQ)

AdventHealth2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
AdventHealth
入组人数
5
试验地点
2
主要终点
Lactation Volume

研究概览

简要总结

This study is designed to investigate whether using osteopathic manipulation can increase the milk supply in lactating women.

详细描述

The short and long-term benefits of breastfeeding to both the mother and infant are well established. Benefits for the child range from protection against common childhood infections, decreased rates of type-2 diabetes and systolic hypertension, lower rate of sudden infant death syndrome, increased performance on intelligence tests, and possible reduction in obesity. Maternal benefits include a reduction in the risk of breast cancer, diabetes, hyperlipidemia, hypertension, myocardial infarction, obesity, and ovarian cancer. Given this evidence the World Health Organization (WHO) and the American Academy of Pediatrics recommend, exclusive breastfeeding of infants for the first six months. WHO goes on to recommend breastfeeding to 2 years and beyond if mutually agreeable to both the mother and child. Despite these benefits and recommendations, according to the Centers for Disease Control and Prevention (CDC) in the United States 81% of infants were started breastfeeding and only 51% continued at 6 months. Perceived or actual low milk supply is one of the most common reasons for discontinuing breastfeeding.

This protocol is designed to investigate scientifically our current osteopathic standard of care. There is no available research data to date specifically on using osteopathic manipulation as an intervention to increase milk supply in lactating women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 - 40
  • Between 2 and 28 weeks postpartum from a live infant birth weighing at least 2500g
  • Desire to exclusively breastfeed
  • Able to provide informed consent
  • Available for the duration of the study
  • 1 hour milk volume of less than 1oz (or 2oz for twins)
  • All current nurslings are the same age

排除标准

  • Current use of domperidone
  • Current use of metoclopramide
  • Current use of silymarin
  • History of breast surgery
  • Current malignancy
  • Current pulmonary embolism or deep vein thrombosis
  • Current medical condition resulting in increased intra-cranial pressure
  • History of insufficient glandular tissue (IGT)

结局指标

主要结局

Lactation Volume

时间窗: Baseline through 4 weeks

Measuring lactation volume after osteopathic manipulation in ounces.

次要结局

  • Change in formula supplementation(Baseline to 4 weeks)
  • Change in reported self-worth(Baseline to 4 weeks)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (2)

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