Electroacupoint for Diminutive Milk Production

NCT06590805 | Recruiting DMC

• 1 other identifier: P.T.1 993
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Therapy; Electrotherapy; Dietary Modification

Keywords

Electroacupoint; Postnatal care; Diminutive milk production; Lactating woman

Outcome Measures

Primary Outcomes (3)

• Change in Baby Weight.

  Measurement of Baby Weight using the Baby Weight Scale.

  Change from Baseline Baby Weight at three months.

• Change in Serum Prolactin Level.

  Measurement of Serum Prolactin Level using the Serum Blood Test.

  Change from Baseline Serum Prolactin Level at three months.

• Change in Flow of Milk.

  Measurement of Flow of Milk using the Visual Analogue Scale.

  Change from Baseline Flow of Milk at three months.

Study Arms (2)

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.

Procedure: Electrotherapy using Chattanooga stimulation unit; Dietary Supplement: Balanced Diet using domperidone drug, iron, and folic acid supplementation.

postnatal care only

ACTIVE COMPARATOR

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

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

Interventions

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.

Electroacupoint combined with postnatal care

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.

Electroacupoint combined with postnatal care; postnatal care only

Eligibility Criteria

• Age: 25 Years - 30 Years
• Gender Eligibility Details: This study is specified for Females who have diminutive milk production.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haytham Ibrahim Morsi: lead

Study Sites (1)

Kafrelsheikh University

Kafrelsheikh, Egypt

RECRUITING

MeSH Terms

Interventions

Iron

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Haytham I Morsi, M.Sc.

  Kafrelsheikh University

  STUDY DIRECTOR

Central Study Contacts

Sara E Seyam, B.Sc.

CONTACT

+201554552868; saraseyam2024@gmail.com

Haytham I Morsi, M.Sc.

CONTACT

+201013657738; haytham_morsi@kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Two Parallel Groups for Comparison.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)