WithdrawnNot Applicable

Effect of Acupuncture on Hypogalactia

Stopped: The PI leaves the study institution.

United States0Started 2019-06

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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.

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

Trial details

NCT IDNCT03851718

SponsorTexas Tech University Health Sciences Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Hypogalactia trials