Auricular Therapy for Postpartum Lactation

NCT03147781 | Completed

• 1 other identifier: HSEARS20170214003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactation; Cesarean

Keywords

auriculotherapy, human milk, breastfeeding, lactogenesis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  first five postpartum days

Secondary Outcomes (3)

• Neonatal behaviors of swallowing and rooting during breastfeeding.

  first five postpartum days

• Neonatal weight

  first five postpartum days

• Frequencies of urination and defecation

  first five postpartum days

Study Arms (3)

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.

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.

Device: True AT with magnetic pellets

Interventions

True AT with magnetic pellets DEVICE

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.

True AT with magnetic pellets

Sham AT with Medulla Junci DEVICE

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.

Sham AT with Medulla Junci

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Love Saint Hospital

Kaohsiung City, 831, Taiwan

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lorna KP Suen, Ph.D

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 10, 2017
• Study Start: April 7, 2017
• Primary Completion: March 8, 2018
• Study Completion: June 8, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)