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Recruiting NCT06590805

Electroacupoint for Diminutive Milk Production

No phase Interventional Physical Therapy Electrotherapy Dietary Modification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrotherapy using Chattanooga stimulation unit, Balanced Diet using domperidone drug, iron, and folic acid supplementation..
Who it may be relevant to
Registry conditions: Physical Therapy, Electrotherapy, Dietary Modification. Basic parameters: 25 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman

Overview

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

Detailed description

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.

Interventions

  • Procedure 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
  • Dietary supplement 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.

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Kafrelsheikh University — Kafrelsheikh

Identifiers

NCT: NCT06590805 · P.T.1 993

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗