EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION

NCT03806062 | Completed Phase 4 DMC

• 1 other identifier: 48
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient lactation. The participants were divided randomly into three equal groups, Group (A) control, Group (B) received low power He-Ne laser beam on both breasts and Group (C) received faradic current stimulation at Spleen 6, Liver 3 and Small Intestine 1 acupuncture points on both sides, all participants received 10 mg domperidone 3 times a day and advice about lactation, nutrition and fluid intake. Evaluation was done before and after the treatment program

Conditions

Insufficient Lactation

Outcome Measures

Primary Outcomes (1)

• serum prolactin

  the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment

  12 weeks after treatment

Study Arms (3)

control group

ACTIVE COMPARATOR

10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks)

Drug: domperidone

Laser group

ACTIVE COMPARATOR

The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session on both breasts. The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions)

Drug: domperidone; Device: He-Ne laser (Bravo TrezaSerie) device

Electro acupuncture group

ACTIVE COMPARATOR

faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze) using surface electrodes

Drug: domperidone; Device: faradic current

Interventions

domperidone DRUG

10 mg domperidone 3 times a day after meals

Electro acupuncture group; Laser group; control group

He-Ne laser (Bravo TrezaSerie) device DEVICE

The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session

Laser group

faradic current DEVICE

faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze)

Electro acupuncture group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Their age ranged between 20 and 35 years old
• to 30 kg/m² body mass index (BMI).
• They attended the breast feeding clinic complaining from insufficiency of lactation within the 1st month after normal vaginal delivery and they were using mixed feeding (Both breast and bottle feeding at least 3 bottles per day and not more than 6 bottles).
• They had approximately the same nutrition as well as, education level

You may not qualify if:

• lactating mothers who suffered from post-partum hemorrhage
• cardio respiratory disease
• diabetes mellitus
• breast cancer
• previous surgeries in the chest, breast or the surrounding area
• anemia
• those who had any causes that hindering their normal breast feeding as (retraced, cracked, inflamed or inverted nipples)
• Women receiving contraceptive pills,
• conditions related to the infant that affect the lactation process were excluded such as congenital conditions of infant mouth: tongue tie, cleft of the soft palate and congenital heart disease of the infant

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

• Maged AM, Hassanin ME, Kamal WM, Abbassy AH, Alalfy M, Askalani AN, El-Lithy A, Nabil M, Farouk D, Hussein EA, Hammad B. Effect of Low-Level Laser Therapy versus Electroacupuncture on Postnatal Scanty Milk Secretion: A Randomized Controlled Trial. Am J Perinatol. 2020 Oct;37(12):1243-1249. doi: 10.1055/s-0039-1693428. Epub 2019 Jul 21.

  PMID: 31327162 DERIVED

MeSH Terms

Conditions

Lactation Disorders

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmed Maged

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 16, 2019
• Study Start: January 2, 2018
• Primary Completion: December 4, 2018
• Study Completion: January 2, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

EG (1)