Insufficient LactationPhase 4NCT03806062
EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION
A Phase 4 study testing domperidone, He-Ne laser (Bravo TrezaSerie) device and faradic current in people with Insufficient Lactation, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Insufficient Lactation
- What is being tested?
- domperidone, He-Ne laser (Bravo TrezaSerie) device and faradic current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2018to 2 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Women in Group (A) acted as a control group and only received medical treatment in the form of 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks) Each woman in group (B) lied in supine lying position on the treatment plinth wearing the protective eyewear as precautionary measures for her safety and exposing her breast out of her clothes then the breast was cleaned by alcohol. The laser apparatus was directed perpendicularly over the treated breast at a distance 50 cm from it, all metal objects must be removed from the range of action of laser (i.e. necklaces). 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 the machine switched off automatically then, it was adjusted again to start irradiation by the same procedures for the other breast. The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions). He-Ne laser (Bravo TrezaSerie) device was used. The equipment was designed in compliance with international technical standards UNI EN ISO 9002 and En 46002 and complies with the safety requirements.
Group (B) had received 12 sessions of irradiation by low power He-Ne laser beam on both sides of the breasts 10 minutes on each side. One session every other day, three sessions weekly for four weeks beside the medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period Group (C) women were treated by 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 in addition to medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake allthrough the treatment period
SP-6 Acupuncture Point lies on the inner leg aspect about 3 cm higher than the medial malleolus, along the posterior tibial border. Fig. (2)
LIV-3 Acupuncture Point is the one that lies in the depressed area between the 1st 2 metatarsal bones proximal to the metatarsophalangeal joints on the dorsal foot aspect Fig. (2)
SI.1 Acupuncture point is located on the little finger, ulnar to the distal phalanx, at the intersection of the vertical line of ulnar border of the nail and the horizontal line of the base of the little fingernail. Fig. (2)
Each woman in group (C) was asked to be in a long sitting or half lying position, When the points were located, the electrodes were fastened securely with an adhesive tape or an elastic band to ensure good contact between the skin and the electrode over the acupuncture points. The intensity control of the stimulator was slowly increased until the patient could just feel the stimulation. The session lasted for 30 minutes. One session every other day, 3 sessions weekly for 4 weeks. (Total 12 sessions).
- Conditions
- Insufficient Lactation
- Being tested
- domperidone, He-Ne laser (Bravo TrezaSerie) device, faradic current
- Medical subject headings
- Lactation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
domperidoneDrug
10 mg domperidone 3 times a day after meals
He-Ne laser (Bravo TrezaSerie) deviceDevice
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
faradic currentDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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 Receives: Drug: domperidone; Device: faradic current |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum prolactin
the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start2 Jan 2018
- Primary completion4 Dec 2018
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insufficient LactationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806062
- Sponsor's protocol ID
- 48
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31327162
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF LOW LEVEL LASER THERAPY VERSUS ELECTROACUPUNCTURE ON POSTNATAL SCANTY MILK SECRETION
- ClinicalTrials.gov ID
- NCT03806062
- Acronym / sponsor ID
- 48
- Conditions
- Insufficient Lactation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Women in Group (A) acted as a control group and only received medical treatment in the form of 10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks) Each woman in group (B) lied in supine lying position on the treatment plinth wearing the protective eyewear as precautionary measures for her safety and exposing her breast out of her clothes then the breast was cleaned by alcohol. The laser apparatus was directed perpendicularly over the treated breast at a distance 50 cm from it, all metal objects must be removed from the range of action of laser (i.e. necklaces). 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 the machine switched off automatically then, it was adjusted again to start irradiation by the same procedures for the other breast. The mother had one session every other day, three sessions weekly for four weeks. (Total 12 sessions). He-Ne laser (Bravo TrezaSerie) device was used. The equipment was designed in compliance with international technical standards UNI EN ISO 9002 and En 46002 and complies with the safety requirements.
Group (B) had received 12 sessions of irradiation by low power He-Ne laser beam on both sides of the breasts 10 minutes on each side. One session every other day, three sessions weekly for four weeks beside the medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period Group (C) women were treated by 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 in addition to medical treatment (10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake allthrough the treatment period
SP-6 Acupuncture Point lies on the inner leg aspect about 3 cm higher than the medial malleolus, along the posterior tibial border. Fig. (2)
LIV-3 Acupuncture Point is the one that lies in the depressed area between the 1st 2 metatarsal bones proximal to the metatarsophalangeal joints on the dorsal foot aspect Fig. (2)
SI.1 Acupuncture point is located on the little finger, ulnar to the distal phalanx, at the intersection of the vertical line of ulnar border of the nail and the horizontal line of the base of the little fingernail. Fig. (2)
Each woman in group (C) was asked to be in a long sitting or half lying position, When the points were located, the electrodes were fastened securely with an adhesive tape or an elastic band to ensure good contact between the skin and the electrode over the acupuncture points. The intensity control of the stimulator was slowly increased until the patient could just feel the stimulation. The session lasted for 30 minutes. One session every other day, 3 sessions weekly for 4 weeks. (Total 12 sessions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: domperidone10 mg domperidone 3 times a day after meals) and advice about lactation, nutrition and fluid intake all through the treatment period (4 weeks) |
| Laser group | Active comparator | Drug: domperidone, Device: He-Ne laser (Bravo TrezaSerie) deviceThe 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) |
| Electro acupuncture group | Active comparator | Drug: domperidone, Device: faradic currentfaradic 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| domperidone10 mg domperidone 3 times a day after meals | Drug | Electro acupuncture group, Laser group, control group |
| He-Ne laser (Bravo TrezaSerie) deviceThe 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 | Device | Laser group |
| faradic currentfaradic 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) | Device | Electro acupuncture group |
Primary outcome
serum prolactin
Time frame: 12 weeks after treatment
the mean difference in the value of serum prolactin between the three studied groups measured at post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 31327162Maged 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing domperidone, He-Ne laser (Bravo TrezaSerie) device and faradic current in people with Insufficient Lactation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum prolactin (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.