Effect of Acupuncture on Hypogalactia (NCT03851718) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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
. 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).