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Acupuncture for Breast Engorgement During Lactation

Primary Purpose

Breast Engorgement

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Engorgement focused on measuring acupuncture, breast engorgement, lactation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Taichung Veterans General Hospital
  • TCMRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

Outcomes

Primary Outcome Measures

breast engorgement
Six-point Engorgement Scale

Secondary Outcome Measures

mastitis
The incidence of mastitis

Full Information

First Posted
July 24, 2017
Last Updated
August 1, 2017
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03230760
Brief Title
Acupuncture for Breast Engorgement During Lactation
Official Title
Acupuncture for Breast Engorgement During Lactation: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
June 26, 2018 (Anticipated)
Study Completion Date
June 26, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Engorgement
Keywords
acupuncture, breast engorgement, lactation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.
Primary Outcome Measure Information:
Title
breast engorgement
Description
Six-point Engorgement Scale
Time Frame
3 days
Secondary Outcome Measure Information:
Title
mastitis
Description
The incidence of mastitis
Time Frame
3 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women with breast engorgement and 20 years old or older Exclusion Criteria: patients with: diabetes mellitus psychological disease or mental illness Fever > 38 degrees Celsius Mastitis analgesics or anti - inflammatory agents used ultrasound therapy applied
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ShuHuey Chou
Phone
886963826707
Email
lummdo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PeiJung Chiang
Organizational Affiliation
Traditional Chinese Medicine department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PeiJung Chiang
Phone
886963826707
Email
aerin.chiang@gmail.com
Facility Name
TCM
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PeiJung Chiang
Phone
886963826707

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27351423
Citation
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.
Results Reference
result
PubMed Identifier
32987448
Citation
Crepinsek 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.
Results Reference
derived
PubMed Identifier
32944940
Citation
Zakarija-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.
Results Reference
derived

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Acupuncture for Breast Engorgement During Lactation

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