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临床试验/NCT06590805
NCT06590805招募中不适用

Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman

Haytham Ibrahim Morsi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
36
试验地点
1
主要终点
Change in Baby Weight.

研究概览

简要总结

The purpose of this study was to reveal the effect of electroacupoint on scanty milk production in lactating women.

详细描述

Postnatal scanty milk secretion is a common complaint. Some physical and medicinal therapies have been proposed to enhance milk production. These therapies must be both successful and safe for both the mother and the child. In many cases, milk supply can be increased by frequent, regular milk removal, Medication to increase milk supply (galactogogues) such as domperidone.

Domperidone has been linked to maternal adverse effects in galactogogue trials and cases reported to the Food and Drug Administration include dry mouth, headache, dizziness, nausea, abdominal cramping, diarrhea, palpitations malaise, and shortness of breath. Some of these were more frequent with dosages greater than with 30 mg daily. Drug withdrawal symptoms consisting of insomnia, anxiety, and tachycardia were reported in a woman taking 80 mg of domperidone daily for 8 months as a galactogogue who abruptly tapered the dose over 3 days.

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
25 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •They were complaining of insufficiency of lactation within the first month after cesarean section.
  • •They are using mixed feeding; both breast and bottle feeding, between three and six bottles per day.
  • •Their age ranged from 25-30 years old.
  • •Their body mass index didn't exceeded 30 kg/m2.

排除标准

  • •Postpartum haemorrhage.
  • •Cardiorespiratory disease.
  • •Diabetes mellitus.
  • •Breast cancer.
  • •Previous surgeries in the chest, breast, or the surrounding area.
  • •Any causes that hindered their normal breastfeeding (retraced, cracked, inflamed, or inverted nipples).
  • •Receiving contraceptive pills.
  • •Having infants with conditions that may affect the lactation process such as congenital abnormalities of the mouth (tongue tie, cleft palate).
  • •Congenital heart disease.

研究组 & 干预措施

Electroacupoint combined with postnatal care

Experimental

Electroacupoint stimulation using the Electroacupoint device and postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care.

干预措施: Electrotherapy using Chattanooga stimulation unit (Procedure)

Electroacupoint combined with postnatal care

Experimental

Electroacupoint stimulation using the Electroacupoint device and postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care.

干预措施: Balanced Diet using domperidone drug, iron, and folic acid supplementation. (Dietary Supplement)

postnatal care only

Active Comparator

Postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care.

干预措施: Balanced Diet using domperidone drug, iron, and folic acid supplementation. (Dietary Supplement)

结局指标

主要结局

Change in Baby Weight.

时间窗: Change from Baseline Baby Weight at three months.

Measurement of Baby Weight using the Baby Weight Scale.

Change in Serum Prolactin Level.

时间窗: Change from Baseline Serum Prolactin Level at three months.

Measurement of Serum Prolactin Level using the Serum Blood Test.

Change in Flow of Milk.

时间窗: Change from Baseline Flow of Milk at three months.

Measurement of Flow of Milk using the Visual Analogue Scale.

次要结局

未报告次要终点

研究者

发起方
Haytham Ibrahim Morsi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Haytham Ibrahim Morsi

Lecturer

Kafrelsheikh University

研究点 (1)

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