Effect of Acupuncture on Hypogalactia

NCT03851718 | Withdrawn FDA Device

• 1 other identifier: L18-195
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims are (1) to assess the feasibility of a RCT studying acupuncture's impact on breast milk production, and (2) to compare the difference of milk production between acupuncture and power pumping. The study approach will be a two-site prospective, non-blinded, two-arm randomized clinical trial conducted in Lubbock and Amarillo as a collaborative effort between researchers and clinicians in the departments of Family Medicine, Pediatrics and Ob/Gyn. An estimated 60 eligible mothers will be recruited and enrolled in the study from both sites. The participants will be randomized 1:1 into either the intervention group or the comparison group. The intervention group will receive three standardized acupuncture sessions, based on previous studies done in China and investigators' practice protocol, in 5 days and the comparison group will perform power pumping in 5 days per provided manual and guidance. The primary outcome is changes of breast milk production and it will be measured by weighing the grams/volume of milk expressed with an electric breast pump over time. The secondary outcome is changes of plasma prolactin and it will be measured by immunoassay. Data will be collected at baseline, right after interventions and two week after interventions to compare the difference of the outcomes. The findings of this study will provide insight to establish a RCT protocol to assess acupuncture's impact on hypogalactia. It may also help establish evidence of acupuncture use for hypogalactia.

Conditions

Hypogalactia

Keywords

Acupuncture; Hypogalactia; Power Pumping; Brest Milk Production

Outcome Measures

Primary Outcomes (2)

• changes of breast milk production volume from based line to within 48 hours after the last intervention session.

  Breast Milk Production will be measured by weighing the grams/volume of milk expressed with an electric breast pump (e.g. Spectra Baby USA) at four sequential hourly intervals including zero time.

  Measurements will be done during the study at baseline and right after (i.e. within 48 hours) after last acupuncture session or power pumping secession.

• changes of breast milk production volume from based line to at 2 weeks after the last intervention session.

  Breast Milk Production will be measured by weighing the grams/volume of milk expressed

  Measurements will be done during the study at baseline and 2 weeks after last acupuncture session or power pumping secession.

Secondary Outcomes (2)

• changes of prolactin level from based line from based line to within 48 hours after the last intervention session.

  Measurements will be done during the study at baseline and right after (i.e. within 48 hours) after last acupuncture session or power pumping secession.

• changes of prolactin level from based line to 2 weeks after the last intervention session.

  Measurements will be done during the study at baseline and 2 weeks after last acupuncture session or power pumping secession.

Study Arms (2)

Acupuncture Procedure

EXPERIMENTAL

Acupuncture is a type of Traditional Chinese Medicine (TCM) therapeutic approaches involving the insertion and manipulation of fine needles in specific points. Mothers in acupuncture group will be given three standardized sessions of acupuncture within 5 weekdays, preferably on 3 consecutive days.

Device: Acupuncture Procedure

Power pumping

ACTIVE COMPARATOR

Power pumping is a pumping strategy that mimics normal infant cluster feedings by repeatedly emptying mother's breast very frequently in an effort to increase breast milk supply. As there is no standardized protocol of power pumping, one of the most popular recommendations will be adapted as the study power pumping instruction. It suggests the mom to set at least one hour and two hours preferably for the power pumping at least three days within a 5 weekday period, preferably on 3 consecutive days.

Behavioral: Power pumping

Interventions

Acupuncture Procedure DEVICE

Each session will run about 30\~40 minutes at the Family Medicine Clinic and performed by a licensed acupuncturist. The expense of all three sessions will be reimbursed by the project, not billed to the participant. The following points CV17, ST18 (bilateral), ST36 (bilateral), SI1(bilateral) and LR3(bilateral) , adopted from TCM classic text and previous studies done in China, will be used for all three sessions .

Acupuncture Procedure

Power pumping BEHAVIORAL

It suggests the mom to set at least one hour and two hours preferably for the power pumping at least three days within a 5 weekday period, preferably on 3 consecutive days. During this one hour, the moms will be advised to pump for 20 minutes, rest for 10 minutes, pump for 10 minutes, then rest for 10 minutes and pump for 10 minutes. Alternatively they can also opt to pump and rest for every 10 minutes during the hour.

Power pumping

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primipara or Multipara woman who had normal pregnancy (gestation ≥ 37 weeks gestation) and gave birth vaginally or by Caesarean section to a single child without complications and who are 2 weeks to 6 months postpartum.
• Estimated milk production of \< 450 g/24 hours (or 450ml/24hours)-by self-report
• A current body mass index (BMI) equal or above 18 kg/m2 and below 35 kg/ m2
• Non-smoker. Subjects who have stopped smoking for \>6 months prior to study start may be included.
• Must be fluent in English conversation, reading and writing.

You may not qualify if:

• Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal systems or presence or history of clinically significant psychiatric, immunological, endocrine or metabolic diseases including gestational or pregestational diabetes, and Polycystic Ovarian syndrome.
• History of breast cancer, breast surgery, or clinically significant abnormalities of the breasts that may affect the milk production and/or flow.
• Use of typical and atypical antipsychotics, drugs/supplements, and/or other approaches that may increase milk production or prolactin levels in patients.
• Consumes alcohol during breastfeeding.
• Current case of infectious mastitis and/or Reynaud's disease of the breast.
• History within the last two years or current abuse of alcohol or drugs.
• Current non-smokers with a history of long-term, heavy smoking (\>10 pack-years).

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Lactation Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yan Zhang, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 22, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

US (1)