Clinical trial NCT06590805: Electroacupoint for Diminutive Milk Production
Official title: Ameliorative Potential of Electroacupoint for Diminutive Milk Production in Lactating Woman
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Therapy
Electrotherapy
Dietary Modification
Keywords: Electroacupoint
Postnatal care
Diminutive milk production
Lactating woman
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 36
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two Parallel Groups for Comparison.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Change in Baby Weight.
timeFrame: Change from Baseline Baby Weight at three months.
measure: Change in Serum Prolactin Level.
timeFrame: Change from Baseline Serum Prolactin Level at three months.
measure: Change in Flow of Milk.
timeFrame: Change from Baseline Flow of Milk at three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Haytham I Morsi, M.Sc.
role: STUDY_DIRECTOR
References: