Status:
WITHDRAWN
Effect of Acupuncture on Hypogalactia
Lead Sponsor:
Texas Tech University Health Sciences Center
Conditions:
Hypogalactia
Eligibility:
FEMALE
18-45 years
Phase:
NA
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...
Detailed Description
As important and beneficial as breastfeeding is to infants and mothers, physicians often feel lack resources to support breast milk production. Reduced breast milk production (called hypogalactia) is ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03851718
Start Date
June 1 2019
End Date
June 1 2020
Last Update
May 3 2019
Active Locations (1)
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1
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430