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NCT Number: NCT06590805

Electroacupoint for Diminutive Milk Production

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

Recruiting

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Key information

Age range

25 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafrelsheikh, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Electrotherapy using Chattanooga stimulation unit

Procedure

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 also associated with decreased risk of infection or bruise.

Balanced Diet using domperidone drug, iron, and folic acid supplementation.

Dietary Supplement

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.

Primary outcomes

  1. Change in Baby Weight.

    Time frame: Change from Baseline Baby Weight at three months.

    Measurement of Baby Weight using the Baby Weight Scale.

  2. Change in Serum Prolactin Level.

    Time frame: Change from Baseline Serum Prolactin Level at three months.

    Measurement of Serum Prolactin Level using the Serum Blood Test.

  3. Change in Flow of Milk.

    Time frame: Change from Baseline Flow of Milk at three months.

    Measurement of Flow of Milk using the Visual Analogue Scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Haytham I Morsi, M.Sc.

CONTACT

[email protected]

+201013657738

Sara E Seyam, B.Sc.

CONTACT

[email protected]

+201554552868

Sponsors and collaborators

Lead sponsor

Haytham Ibrahim Morsi

Other

Registry information

Official study title

Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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