NCT04416880

Brief Summary

This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 1, 2020

Last Update Submit

June 3, 2020

Conditions

Lactation; Insufficient, PartialHypogalactia, Without Mention of Attachment Difficulty

Keywords

acupunctureexclusive breastfeedingbreastmilkpress tack needlelactation insufficiency

Outcome Measures

Primary Outcomes (2)

  • Breastmilk Volume

    Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump

    Day 7 of acupuncture or sham treatment

  • Breastmilk Volume

    Pre- and Post Treatment Breastmilk Volume were measured using electric breast pump

    Day 10 of acupuncture or sham treatment (Day 3 after press tack needles were removed)

Study Arms (2)

Press Tack Needle Acupuncture

EXPERIMENTAL

Patients in this group were given seirin pyonex press tack needle treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.

Device: Press Tack Needle Acupuncture

Sham Control Press Tack Needle Acupuncture

SHAM COMPARATOR

Patients in this group were given sham treatment in the acupuncture points CV17 Danzhong and SI1 Shaoze bilateral for 7 days.

Device: Press Tack Needle Acupuncture

Interventions

Press Tack Needle AcupunctureDEVICE

Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point

Press Tack Needle AcupunctureSham Control Press Tack Needle Acupuncture

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreastfeeding mothers
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Breastfeeding mother who suffers from lactation insufficiency
  • Breastfeeding mother from 2 weeks to 5 months post-partum
  • Breastfeeding mother with healthy baby

You may not qualify if:

  • Subject consumes drugs that are known to decrease breastmilk production
  • Subject with infection or inflammation in the intended acupuncture points
  • Subject with bleeding disorder
  • Subject consumes anticoagulant
  • Subject with known diabetic history
  • Subject with body temperature \> 38 degree celcius

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Puskesmas Kecamatan Menteng

Jakarta Pusat, DKI Jakarta, 10310, Indonesia

Location

Poliklinik Akupunktur Medik RSCM

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Puskesmas Kelurahan Pegangsaan

Jakarta Pusat, DKI Jakarta, 13150, Indonesia

Location

MeSH Terms

Conditions

Breast FeedingLactation Disorders

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Diana Oei, MD

    Faculty of Medicine University of Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

December 13, 2019

Primary Completion

February 18, 2020

Study Completion

February 18, 2020

Last Updated

June 5, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

ID(3)