Breast EngorgementNCT03230760
Acupuncture for Breast Engorgement During Lactation
A study testing acupuncture in people with Breast Engorgement, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
Trial summary
Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Engorgement
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 18 Jul 2017to 26 Jun 2018
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with breast engorgement and 20 years old or older
Who cannot join
- patients with:
- diabetes mellitus
- psychological disease or mental illness
- Fever > 38 degrees Celsius
- Mastitis
- analgesics or anti - inflammatory agents used
- ultrasound therapy applied
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407
PeiJung Chiang, 886963826707, aerin.chiang@gmail.com
- Recruiting
TCM
Taichung, 407
PeiJung Chiang, 886963826707
About this study
Official title: Acupuncture for Breast Engorgement During Lactation: a Pilot Study.
Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct.
According the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement.
The investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied
- Conditions
- Breast Engorgement
- Being tested
- acupuncture
- Keywords
- acupuncture, breast engorgement, lactation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Device: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast engorgement
Six-point Engorgement Scale
Measured: 3 days
Secondary outcomes (1)
mastitis
The incidence of mastitis
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start18 Jul 2017
- Primary completion26 Jun 2018 (estimated)
- Study completion26 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast EngorgementStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PeiJung Chiang, Taichung Veterans General Hospital
- Investigators
- PeiJung Chiang, Principal investigator, Traditional Chinese Medicine department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230760
- Sponsor's protocol ID
- CF17141A
- Status last verified
- Aug 2017
- First submitted
- 24 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3.
PubMed 27351423Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
PubMed 32987448Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
PubMed 32944940
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Breast Engorgement During Lactation: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03230760
- Acronym / sponsor ID
- CF17141A
- Conditions
- Breast Engorgement
- Keywords
- acupuncture, breast engorgement, lactation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 26 Jun 2018 (estimated)
- Study completion
- 26 Jun 2018 (estimated)
- First posted
- 26 Jul 2017 (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.
Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct.
According the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement.
The investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever > 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: acupuncture |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with breast engorgement and 20 years old or older
Key exclusion criteria (7 listed)
- patients with:
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 |
|---|---|---|
| acupunctureDevice: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body. | Device | treatment |
Primary outcome
breast engorgement
Time frame: 3 days
Six-point Engorgement Scale
1 secondary outcome
mastitis
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Results publication: PubMed 27351423Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;2016(6):CD006946. doi: 10.1002/14651858.CD006946.pub3.
- Derived from this study: PubMed 32987448Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
- Derived from this study: PubMed 32944940Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
- Individual participant dataSharing planned: No
Related trials for Breast Engorgement
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Breastfeeding, Breastfeeding Self-Efficacy
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Breastfeeding Education Through Clinical Demonstration for Primiparous Women to Prevent Sore Nipples and Engorgement
Nipple Infection, Nipple Discharge
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Breast Engorgement
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.
PeiJung Chiang principal investigator
Traditional Chinese Medicine department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Breast Engorgement, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ShuHuey Chou (886963826707, lummdo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast engorgement (time frame: 3 days). 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 NCT03230760, which also lists 3 linked publications.
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 2 Aug 2017.