Effect of Acupuncture on Hypogalactia

Withdrawn before enrolling · Not applicable

Conditions studied: Hypogalactia

In brief

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.

Key facts

Study ID

NCT03851718

Run by

Texas Tech University Health Sciences Center

People needed

0

Starts

2019-06-01

Expected to finish

2020-06-01

Last updated by the study team

2019-05-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

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).

Where it is running

• Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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