Acupuncture for Breast Engorgement During Lactation

Breast Engorgement Clinical Trial

Official title:

Acupuncture for Breast Engorgement During Lactation: a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230760
• Other study ID #: CF17141A
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2017
• Last updated: August 1, 2017
• Start date: July 18, 2017
• Est. completion date: June 26, 2018

Study information

• Verified date: August 2017
• Source: Taichung Veterans General Hospital
• Contact: ShuHuey Chou
• Phone: 886963826707
• Email: lummdo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• women with breast engorgement and 20 years old or older

Exclusion Criteria:

• patients with:

1. diabetes mellitus

2. psychological disease or mental illness

3. Fever > 38 degrees Celsius

4. Mastitis

5. analgesics or anti - inflammatory agents used

6. ultrasound therapy applied

Related Conditions & MeSH terms

• Breast Engorgement
• Hyperemia

Intervention

Device:
• acupuncture
Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	TCM	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Mangesi L, Zakarija-Grkovic I. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2016 Jun 28;(6):CD006946. doi: 10.1002/14651858.CD006946.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast engorgement	Six-point Engorgement Scale	3 days
Secondary	mastitis	The incidence of mastitis	3 days