Electroacupoint for Diminutive Milk Production

NCT ID: NCT06590805

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-01

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.

Conditions

Physical Therapy; Electrotherapy; Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electroacupoint combined with postnatal care

Electroacupoint stimulation using the Electroacupoint device and postnatal care diet in form of balanced diet and drinking sufficient clean water and routine postnatal care.

Group Type: EXPERIMENTAL

Electrotherapy using Chattanooga stimulation unit

Intervention Type: 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.

Intervention Type: 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.

postnatal care only

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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 also associated with decreased risk of infection or bruise.

Intervention Type: PROCEDURE

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Haytham Ibrahim Morsi

OTHER

Sponsor Role: lead

Responsible Party

Haytham Ibrahim Morsi

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Haytham I Morsi, M.Sc.

Role: STUDY_DIRECTOR

Kafrelsheikh University

Locations

Kafrelsheikh University

Kafrelsheikh, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sara E Seyam, B.Sc.

Role: CONTACT

saraseyam2024@gmail.com

+201554552868

Haytham I Morsi, M.Sc.

Role: CONTACT

haytham_morsi@kfs.edu.eg

+201013657738

Other Identifiers

P.T.1 993

Identifier Type: -

Identifier Source: org_study_id