LactationNCT03147781
Auricular Therapy for Postpartum Lactation
A study testing True AT with magnetic pellets in people with Lactation and Cesarean, run by The Hong Kong Polytechnic University at 1 site in Taiwan.
Trial summary
The aim of this study is to function as a pilot study in evaluating the effects of auricular therapy (AT) on lactation for women in the immediate post cesarean period while examining the feasibility of the three-parallel-arm, sham-controlled randomized design. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- True AT with magnetic pellets
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2017to 8 Jun 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers and their term (37-42 weeks) and singleton infants
- Has cesarean section at the study hospital, irrespective of the reason for cesarean (primary, repeated, indicated, elective, scheduled, unscheduled, emergency, or non-emergency)
- Intent to stay hospitalized for at least 96 hours after birth
- Intent to breastfeed
- Able to communicate with Chinese, Taiwanese, or English
Who cannot join
- Mothers and their preterm infants (<37 weeks), postterm infants (>42weeks)
- Infants who are not able to be breastfed
- Acute and chronic maternal health problems that can affect lactation. 3.1 Acute illness and infections: e.g. tuberculosis, Group B Streptococcus, Methicillin-Resistant Staphylococcus Aureus (MRSA), etc. 3.2 Alternations in endocrine and metabolic functioning: hypothyroidism, hypopituitarism, diabetes, Sheenhan's syndrome, gestational ovarian theca lutein cysts, polycystic ovarian syndrome. 3.3 Breast-related problems, e.g., breast surgery, injury, and cancer, etc. 3.4 Perinatal conditions: placental retention, dysfunctional uterine bleeding.
- Skin conditions in the ear such as rashes, moles, scars, irritation or ear abrasions.
- Has an implanted electrical device (for example, a pacemaker).
- Has earrings on the selected auricular acupoints.
- Had been receiving auricular therapy within the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Auricular Therapy on Lactation: A Pilot Study
The aim of this study is to function as a pilot study in evaluating the effects of auricular therapy (AT) on lactation for women in the immediate post cesarean period while examining the feasibility of the three-parallel-arm, sham-controlled randomized design. The study hypothesizes that post cesarean women who receive AT with standard care for 96 hours postpartum have earlier onset of lactogenesis II and larger milk production when compared with women who receive sham AT with standard care or standard care alone.
Read the detailed description
Breastfeeding has been of major concern in maternal-child healthcare. Challenges posed by cesarean delivery can have negative impacts on breastfeeding. Efforts to facilitate, support, and sustain breastfeeding have been investigated to a great extent by researchers from a variety of disciplines. In the field of Traditional Chinese Medicine (TCM), a number of clinical studies have been carried out to study the effect of auricular therapy (AT) on postpartum lactation over the years. Limitations in the evidence that currently exists include the lack of randomization, sham-controlled treatment, blinding and/or no valid outcome measures. Given that such information is important for maternal-child health and clinical practice, the study has set out to conduct a pilot trial which employs randomized, single-blinded, and sham group design that examines relevant outcomes using valid measurement.
A total of 96 post cesarean participants have been randomly assigned to one of three treatment conditions: (1) standard care (n=32); (2) standard care with Medulla Junci adhesive on auricular acupoints (n=32); (3) standard care with magnetic pellets adhesive on auricular acupoints (n=32). The standard care group participants only received the standard post cesarean care of the study hospital without any additional therapies. The same set of six pre-specified auricular points were adopted for both Medulla Junci and magnetic pellets groups. The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during their hospital stay at a maternal hospital in Kaohsiung, Taiwan.
Milk production and onset of lactogenesis II have been used as primary outcome variables for the evaluation of the effectiveness of AT. Milk production is determined by the summed value of infant test weighing measurements and expressed breast milk. Maternal perceptions of breast fullness, swelling, leakage, or tingling are the indicator of onset of lactogenesis II. The secondary outcome measures are infant behaviors of observed swallowing and rooting during breastfeeding, neonatal weight gain, and frequencies of urination and defecation of the infant.
Numeric rating scales have been used to measure the effect of the possible mediating variables, i.e., pain and stress. Potential confounding variables have been controlled by either stratified randomization and exclusion criteria or monitored during the study period. Treatment expectation and satisfaction toward AT have been assessed in order to examine their relationship with therapy outcomes. Main components of study feasibility, i.e., recruitment, retention, and acceptance, have been evaluated. Participants also have been contacted to acquire their one and three-month breastfeeding practice status.
- Being tested
- True AT with magnetic pellets, Sham AT with Medulla Junci
- Keywords
- auriculotherapy, human milk, breastfeeding, lactogenesis
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True AT with magnetic pelletsDevice
Magnetic pellets are affixed onto pre-selected auricular acupoints with tape.The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during the hospital stay.
Sham AT with Medulla JunciDevice
Medulla Junci segments are crumbled into ball-shape and then attached to the pre-selected auricular acupoints with tape. The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during the hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Participants in this group only receive standard post-cesarean care of the study hospital. It includes mobility restraint, foley retention, IV fluid infusion, oral intake instructions, oral pain medications routine, and breastfeeding practice. |
| Sham AT with Medulla Junci | Sham comparator | Participants in this group receive auricular tape with Medulla Junci in addition to standard post-cesarean care during the early 96 postpartum hours. Receives: Device: Sham AT with Medulla Junci |
| True AT with magnetic pellets | Experimental | Participants in this group receive auricular tape with magnetic pellets in addition to standard post-cesarean care during the early 96 postpartum hours. Receives: Device: True AT with magnetic pellets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of lactogenesis II
Maternal perception of breast symptoms of lactation, i.e., breast fullness, swelling, leakage, or tingling, are employed in identifying onset of lactogenesis II. Assessment of maternal perception began within 4 to 8 hours postpartum. Participants was instructed to record the approximate time when breast symptoms of lactation first noticed. They was interviewed regarding these breast symptoms twice daily during their hospital stay.
Measured: up to five postpartum days
Change of Milk production
Milk production is determined by the summed value of infant test weighing measurements and expressed breast milk. Test weighing procedure, whereby the infant is weighted under exactly the same clothing and diaper immediately before and after feeding to estimate milk intake during breastfeeding.
Measured: first five postpartum days
Secondary outcomes (3)
Neonatal behaviors of swallowing and rooting during breastfeeding.
Infants were observed by the study assessor during breastfeeding once daily. The result obtained from this outcome will assist the evaluation of milk production change.
Measured: first five postpartum days
Neonatal weight
The data were collected from the nursery record.The result obtained from this outcome will assist the evaluation of milk production change.
Measured: first five postpartum days
Frequencies of urination and defecation
The data were collected from the nursery record.The result obtained from this outcome will assist the evaluation of milk production change.
Measured: first five postpartum days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start7 Apr 2017
- Primary completion8 Mar 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorna KP Suen, Ph.D, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147781
- Sponsor's protocol ID
- HSEARS20170214003
- Status last verified
- Jun 2018
- First submitted
- 27 Apr 2017
- Last updated
- 12 Jun 2018
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auricular Therapy on Lactation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03147781
- Acronym / sponsor ID
- HSEARS20170214003
- Keywords
- auriculotherapy, human milk, breastfeeding, lactogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 10 May 2017 (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.
The aim of this study is to function as a pilot study in evaluating the effects of auricular therapy (AT) on lactation for women in the immediate post cesarean period while examining the feasibility of the three-parallel-arm, sham-controlled randomized design. The study hypothesizes that post cesarean women who receive AT with standard care for 96 hours postpartum have earlier onset of lactogenesis II and larger milk production when compared with women who receive sham AT with standard care or standard care alone.
Detailed description
Breastfeeding has been of major concern in maternal-child healthcare. Challenges posed by cesarean delivery can have negative impacts on breastfeeding. Efforts to facilitate, support, and sustain breastfeeding have been investigated to a great extent by researchers from a variety of disciplines. In the field of Traditional Chinese Medicine (TCM), a number of clinical studies have been carried out to study the effect of auricular therapy (AT) on postpartum lactation over the years. Limitations in the evidence that currently exists include the lack of randomization, sham-controlled treatment, blinding and/or no valid outcome measures. Given that such information is important for maternal-child health and clinical practice, the study has set out to conduct a pilot trial which employs randomized, single-blinded, and sham group design that examines relevant outcomes using valid measurement.
A total of 96 post cesarean participants have been randomly assigned to one of three treatment conditions: (1) standard care (n=32); (2) standard care with Medulla Junci adhesive on auricular acupoints (n=32); (3) standard care with magnetic pellets adhesive on auricular acupoints (n=32). The standard care group participants only received the standard post cesarean care of the study hospital without any additional therapies. The same set of six pre-specified auricular points were adopted for both Medulla Junci and magnetic pellets groups. The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during their hospital stay at a maternal hospital in Kaohsiung, Taiwan.
Milk production and onset of lactogenesis II have been used as primary outcome variables for the evaluation of the effectiveness of AT. Milk production is determined by the summed value of infant test weighing measurements and expressed breast milk. Maternal perceptions of breast fullness, swelling, leakage, or tingling are the indicator of onset of lactogenesis II. The secondary outcome measures are infant behaviors of observed swallowing and rooting during breastfeeding, neonatal weight gain, and frequencies of urination and defecation of the infant.
Numeric rating scales have been used to measure the effect of the possible mediating variables, i.e., pain and stress. Potential confounding variables have been controlled by either stratified randomization and exclusion criteria or monitored during the study period. Treatment expectation and satisfaction toward AT have been assessed in order to examine their relationship with therapy outcomes. Main components of study feasibility, i.e., recruitment, retention, and acceptance, have been evaluated. Participants also have been contacted to acquire their one and three-month breastfeeding practice status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Participants in this group only receive standard post-cesarean care of the study hospital. It includes mobility restraint, foley retention, IV fluid infusion, oral intake instructions, oral pain medications routine, and breastfeeding practice. |
| Sham AT with Medulla Junci | Sham comparator | Device: Sham AT with Medulla JunciParticipants in this group receive auricular tape with Medulla Junci in addition to standard post-cesarean care during the early 96 postpartum hours. |
| True AT with magnetic pellets | Experimental | Device: True AT with magnetic pelletsParticipants in this group receive auricular tape with magnetic pellets in addition to standard post-cesarean care during the early 96 postpartum hours. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mothers and their term (37-42 weeks) and singleton infants
- Has cesarean section at the study hospital, irrespective of the reason for cesarean (primary, repeated, indicated, elective, scheduled, unscheduled, emergency, or non-emergency)
- Intent to stay hospitalized for at least 96 hours after birth
- Intent to breastfeed
- Able to communicate with Chinese, Taiwanese, or English
Key exclusion criteria (7 listed)
- Mothers and their preterm infants (<37 weeks), postterm infants (>42weeks)
- Infants who are not able to be breastfed
- Acute and chronic maternal health problems that can affect lactation. 3.1 Acute illness and infections: e.g. tuberculosis, Group B Streptococcus, Methicillin-Resistant Staphylococcus Aureus (MRSA), etc. 3.2 Alternations in endocrine and metabolic functioning: hypothyroidism, hypopituitarism, diabetes, Sheenhan's syndrome, gestational ovarian theca lutein cysts, polycystic ovarian syndrome. 3.3 Breast-related problems, e.g., breast surgery, injury, and cancer, etc. 3.4 Perinatal conditions: placental retention, dysfunctional uterine bleeding.
- Skin conditions in the ear such as rashes, moles, scars, irritation or ear abrasions.
- Has an implanted electrical device (for example, a pacemaker).
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 |
|---|---|---|
| True AT with magnetic pelletsMagnetic pellets are affixed onto pre-selected auricular acupoints with tape.The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during the hospital stay. | Device | True AT with magnetic pellets |
| Sham AT with Medulla JunciMedulla Junci segments are crumbled into ball-shape and then attached to the pre-selected auricular acupoints with tape. The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during the hospital stay. | Device | Sham AT with Medulla Junci |
Primary outcome
Onset of lactogenesis II
Time frame: up to five postpartum days
Maternal perception of breast symptoms of lactation, i.e., breast fullness, swelling, leakage, or tingling, are employed in identifying onset of lactogenesis II. Assessment of maternal perception began within 4 to 8 hours postpartum. Participants was instructed to record the approximate time when breast symptoms of lactation first noticed. They was interviewed regarding these breast symptoms twice daily during their hospital stay.
Change of Milk production
Time frame: first five postpartum days
Milk production is determined by the summed value of infant test weighing measurements and expressed breast milk. Test weighing procedure, whereby the infant is weighted under exactly the same clothing and diaper immediately before and after feeding to estimate milk intake during breastfeeding.
3 secondary outcomes
Neonatal behaviors of swallowing and rooting during breastfeeding.
Time frame: first five postpartum days
Neonatal weight
Time frame: first five postpartum days
Frequencies of urination and defecation
Time frame: first five postpartum days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Lorna KP Suen, Ph.D principal investigator
The Hong Kong Polytechnic 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 True AT with magnetic pellets in people with Lactation and Cesarean, run by The Hong Kong Polytechnic University 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 7 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: finished, as of the sponsor's last update on 12 Jun 2018. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Onset of lactogenesis II (time frame: up to five postpartum days). The study lists 2 primary outcomes in all. 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 12 Jun 2018.