Electroacupoint for Diminutive Milk Production

Официальное название

Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Electrotherapy using Chattanooga stimulation unit
  Electroacupoint stimulation using the Chattanooga intellect transport 2-channel electrotherapy stimulation unit 2783. It uses the influences energy flows by needling the acupuncture points which lie along the body meridians to achieve a harmonious balance between physical, emotional, and spiritual states. The same effect can be achieved without the use of needles. These needleless stimulations are noninvasive and nontraumatic and are useful for individuals who are scared of needles. They are als
• Пищевая добавка Balanced Diet using domperidone drug, iron, and folic acid supplementation.
  Postnatal care diet in form of balanced diet using domperidone drug, iron, and folic acid supplementation. Additionally, drinking sufficient clean water and routine postnatal care. It was performed by asking the participant to take ten mg domperidone three times a day after meals. Iron and folic acid supplementation were also continue for three months after birth.

Первичные конечные точки

• Change in Baby Weight. [Срок оценки: Change from Baseline Baby Weight at three months.]
• Change in Serum Prolactin Level. [Срок оценки: Change from Baseline Serum Prolactin Level at three months.]
• Change in Flow of Milk. [Срок оценки: Change from Baseline Flow of Milk at three months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Postpartum haemorrhage.
• Cardiorespiratory disease.
• Diabetes mellitus.
• Breast cancer.
• Previous surgeries in the chest, breast, or the surrounding area.
• Anemia.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Kafrelsheikh University — Kafrelsheikh

Идентификаторы

NCT: NCT06590805 · P.T.1 993

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗