Auricular Therapy for Postpartum Lactation

June 11, 2018 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 831
        • Love Saint Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Mothers and their term (37-42 weeks) and singleton infants
  2. Has cesarean section at the study hospital, irrespective of the reason for cesarean (primary, repeated, indicated, elective, scheduled, unscheduled, emergency, or non-emergency)
  3. Intent to stay hospitalized for at least 96 hours after birth
  4. Intent to breastfeed
  5. Able to communicate with Chinese, Taiwanese, or English

Exclusion Criteria:

  1. Mothers and their preterm infants (<37 weeks), postterm infants (>42weeks)
  2. Infants who are not able to be breastfed
  3. 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.
  4. Skin conditions in the ear such as rashes, moles, scars, irritation or ear abrasions.
  5. Has an implanted electrical device (for example, a pacemaker).
  6. Has earrings on the selected auricular acupoints.
  7. Had been receiving auricular therapy within the past six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Standard care
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_COMPARATOR: Sham AT with Medulla Junci
Participants in this group receive auricular tape with Medulla Junci in addition to standard post-cesarean care during the early 96 postpartum hours.
Device: Sham AT with Medulla Junci
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.
EXPERIMENTAL: True AT with magnetic pellets
Participants in this group receive auricular tape with magnetic pellets in addition to standard post-cesarean care during the early 96 postpartum hours.
Device: True AT with magnetic pellets
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to five postpartum days
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.
first five postpartum days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neonatal behaviors of swallowing and rooting during breastfeeding.
Time Frame: first five postpartum days
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.
first five postpartum days
Neonatal weight
Time Frame: first five postpartum days
The data were collected from the nursery record.The result obtained from this outcome will assist the evaluation of milk production change.
first five postpartum days
Frequencies of urination and defecation
Time Frame: first five postpartum days
The data were collected from the nursery record.The result obtained from this outcome will assist the evaluation of milk production change.
first five postpartum days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lorna KP Suen, Ph.D, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20170214003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cesarean

Clinical Trials on Sham AT with Medulla Junci

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings