NCT03230760

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

July 24, 2017

Last Update Submit

August 1, 2017

Conditions

Breast Engorgement

Keywords

acupuncturebreast engorgementlactation

Outcome Measures

Primary Outcomes (1)

  • breast engorgement

    Six-point Engorgement Scale

    3 days

Secondary Outcomes (1)

  • mastitis

    3 days

Study Arms (1)

treatment

EXPERIMENTAL
Device: acupuncture

Interventions

acupunctureDEVICE

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

treatment

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with breast engorgement and 20 years old or older

You may not qualify if:

  • patients with:
  • diabetes mellitus
  • psychological disease or mental illness
  • Fever \> 38 degrees Celsius
  • Mastitis
  • analgesics or anti - inflammatory agents used
  • ultrasound therapy applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

NOT YET RECRUITING

TCM

Taichung, 407, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27351423RESULT

  • 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.

    PMID: 32987448DERIVED

  • 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.

    PMID: 32944940DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • PeiJung Chiang

    Traditional Chinese Medicine department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ShuHuey Chou

CONTACT

886963826707lummdo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 26, 2017

Study Start

July 18, 2017

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

August 2, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)