Breast Engorgement in PuerperiumETBEGNCT04998565
Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement
A study testing Routine care, Electrical Acupuncture and Transcutaneous Electrical Nerve Stimulation in people with Breast Engorgement in Puerperium and Post Partum Depression, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Engorgement in Puerperium, Post Partum Depression
- What is being tested?
- Routine care, Electrical Acupuncture and Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Sep 2017to 31 Jul 2019
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age > 37 wk
- Delivery of singleton, healthy newborn baby
- Within 7 days postpartum
- Within 24 hours from initial painful breast engorgement
- Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)
Who cannot join
- Fever>37.5∘C
- Mastitis or breast abscess
- Signs of sepsis or other infection
- Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
- Psychological diseases
- Bleeding tendency
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- Artificial valves
- Pacemaker
- Epilepsy
- Consciousness disturbance
- Skin infections
- Hepatitis B carrier
- Acquired Immune Deficiency Syndrome
- Breast tumors
- Breast Surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the add-on Effectiveness of Electro-acupuncture or Transcutaneous Electrical Nerve Stimulation in Early Postpartum Breast Engorgement: A Pilot Randomized Pragmatic Trial
A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.
Read the detailed description
Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.
- Being tested
- Routine care, Electrical Acupuncture, Transcutaneous Electrical Nerve Stimulation
- Keywords
- Electrical acupuncture, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Reverse pressure applied to the areola
Electrical AcupunctureProcedure or surgery
Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
Transcutaneous Electrical Nerve StimulationProcedure or surgery
Transcutaneous electrical nerve stimulation over bil breasts
| Study group | Role | What they receive |
|---|---|---|
| Routine care | Experimental | Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. Receives: Other: Routine care |
| Routine care plus EA | Experimental | Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.
plus: Electrical acupuncture on body acupoints Receives: Other: Routine care; Procedure: Electrical Acupuncture |
| Routine care plus TENS | Experimental | Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.
plus: Transcutaneous electrical nerve stimulation on breasts Receives: Other: Routine care; Procedure: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Index (0-19)
Sum of the degree of Erythema, Tension and Pain scores over breasts
Measured: Changes from Baselines of Severity Index, at each treatment and 1 month later
Secondary outcomes (2)
EPDS
Edinburgh Postnatal Depression Scale
Measured: Changes from Baseline of EPDS, after each treatment and 1 month later
BSES-SF
Breastfeeding Self-Efficacy Scale
Measured: Changes from Baseline of BEES-SF, after each treatment and 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start12 Sep 2017
- Primary completion30 Jun 2018
- Study completion31 Jul 2019
Why it stopped: No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Engorgement in PuerperiumStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Rong Yen, PhD, Study chair, Department of Chinese Medicine, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998565
- Sponsor's protocol ID
- CMUH106-REC1-101
- Acronym
- ETBEG
- Status last verified
- Aug 2021
- First submitted
- 8 Oct 2017
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the add-on Effectiveness of Electro-acupuncture or Transcutaneous Electrical Nerve Stimulation in Early Postpartum Breast Engorgement: A Pilot Randomized Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04998565
- Acronym / sponsor ID
- ETBEG / CMUH106-REC1-101
- Keywords
- Electrical acupuncture, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 10 Aug 2021 (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.
A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.
Detailed description
Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine care | Experimental | Other: Routine careRoutine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. |
| Routine care plus EA | Experimental | Other: Routine care, Procedure: Electrical AcupunctureRoutine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. plus: Electrical acupuncture on body acupoints |
| Routine care plus TENS | Experimental | Other: Routine care, Procedure: Transcutaneous Electrical Nerve StimulationRoutine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk. plus: Transcutaneous electrical nerve stimulation on breasts |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age > 37 wk
- Delivery of singleton, healthy newborn baby
- Within 7 days postpartum
- Within 24 hours from initial painful breast engorgement
- Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)
Key exclusion criteria (15 listed)
- Fever>37.5∘C
- Mastitis or breast abscess
- Signs of sepsis or other infection
- Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
- Psychological diseases
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 |
|---|---|---|
| Routine careReverse pressure applied to the areola | Other | Routine care, Routine care plus EA, Routine care plus TENS |
| Electrical AcupunctureAcupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation | Procedure or surgery | Routine care plus EA |
| Transcutaneous Electrical Nerve StimulationTranscutaneous electrical nerve stimulation over bil breasts | Procedure or surgery | Routine care plus TENS |
Primary outcome
Severity Index (0-19)
Time frame: Changes from Baselines of Severity Index, at each treatment and 1 month later
Sum of the degree of Erythema, Tension and Pain scores over breasts
2 secondary outcomes
EPDS
Time frame: Changes from Baseline of EPDS, after each treatment and 1 month later
BSES-SF
Time frame: Changes from Baseline of BEES-SF, after each treatment and 1 month later
Results and safety
The study was stopped early (reason given: No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
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.
Hung-Rong Yen, PhD study chair
Department of Chinese Medicine, China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care, Electrical Acupuncture and Transcutaneous Electrical Nerve Stimulation in people with Breast Engorgement in Puerperium and Post Partum Depression, run by China Medical University Hospital at 1 site 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: No grants from the Ministry of Science and Technology or school grants, no funds can be executed, so the application is terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity Index (0-19) (time frame: Changes from Baselines of Severity Index, at each treatment and 1 month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2021.