Insufficient Lactation Clinical Trial
Official title:
EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION
NCT number | NCT03806062 |
Other study ID # | 48 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2, 2018 |
Est. completion date | January 2, 2019 |
Verified date | January 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2, 2019 |
Est. primary completion date | December 4, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Their age ranged between 20 and 35 years old - 25 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alainy medical school | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum prolactin | the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment | 12 weeks after treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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