Clinical trial NCT03147781: Auricular Therapy for Postpartum Lactation
Official title: The Effect of Auricular Therapy on Lactation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Cesarean
Keywords: auriculotherapy, human milk, breastfeeding, lactogenesis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 96
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Onset of lactogenesis II
timeFrame: up to five postpartum days
measure: Change of Milk production
timeFrame: first five postpartum days
Secondary outcomes:
measure: Neonatal behaviors of swallowing and rooting during breastfeeding.
timeFrame: first five postpartum days
measure: Neonatal weight
timeFrame: first five postpartum days
measure: Frequencies of urination and defecation
timeFrame: first five postpartum days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Love Saint Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Lorna KP Suen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: