Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding
NCT ID: NCT00405158
Last Updated: 2006-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2002-01-31
2004-03-31
Brief Summary
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Detailed Description
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Design: randomised, non-blinded, controlled trial of acupuncture and care interventions.
Setting: a midwife-led breast-feeding clinic in Sweden.
Participants: 205 mothers with 210 cases of inflammatory symptoms of the breast during lactation agreed to participate. The mothers were randomly assigned to one of three treatment groups, two of which included acupuncture amongst the care interventions and one without acupuncture. All groups were given essential care. Protocols, which included scales for erythema, breast tension and pain, were maintained for each day of contact with the breast-feeding clinic. A Severity Index (SI) for each mother and each day was created by adding together the scores on the erythema, breast tension and pain scales. The range of the SI was 0 (least severe) to 19 (most severe).
Findings: There was no significant difference in numbers of mothers in the treatment groups with the lowest possible score for severity of symptoms on contact days 3, 4 or 5. There were no statistically significant differences between the treatment groups for number of contact days needed until the mother felt well enough to discontinue contact with the breast-feeding clinic or for number of mothers prescribed antibiotics. There were significant differences in the mean SI scores on contact days 3 and 4 between the non-acupuncture group and the two acupuncture groups. Mothers with less favourable outcomes (≥ 6 contact days, n = 61) were, at first contact with the midwife more often given advice on correction of the baby's attachment to the breast. An obstetrician was called to examine 20 % of the mothers and antibiotic therapy was prescribed for 15 % of the study population. The presence of Group B streptococci in the breast milk was related to less favourable outcomes.
Key conclusions and implications for practice: If acupuncture treatment is acceptable to the mother, this, together with care interventions such as correction of breast-feeding position and babies' attachment to the breast might be a more expedient and less invasive choice of treatment than the use of oxytocin nasal spray. Midwives, nurses or medical practitioners with specialist competence in breast feeding should be the primary care providers for mothers with inflammatory symptoms of the breast during lactation. The use of antibiotics for inflammatory symptoms of the breast should be closely monitored in order to help the global community reduce resistance development among bacterial pathogens.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Acupuncture treatment
Administration of oxytocin nasal spray
Improved breast milk removal
Warmth applied to breasts
Breast massage
Anti-pyretic medication, paracetamol
cefadroxil
penicillin
flucloxacillin
Eligibility Criteria
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Inclusion Criteria
* Any mixture of increased breast tension, fever, breast erythema, lumps in the breast
Exclusion Criteria
* Psychiatric illness
* Hemorrhagic disease
* Prosthetic heart valves
* Skin infections
* Hepatitis B
* HIV positive.
FEMALE
No
Sponsors
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Karlstad University
OTHER
Principal Investigators
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Linda J Kvist, PhD
Role: PRINCIPAL_INVESTIGATOR
Karlstads University
Bodil Wilde Larsson, PhD
Role: STUDY_DIRECTOR
Karlstad University
Locations
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Dept Obstetrics & Gynecology, Helsingborg Hospital
Helsingborg, Skåne County, Sweden
Countries
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References
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Kvist LJ, Hall-Lord ML, Rydhstroem H, Larsson BW. A randomised-controlled trial in Sweden of acupuncture and care interventions for the relief of inflammatory symptoms of the breast during lactation. Midwifery. 2007 Jun;23(2):184-95. doi: 10.1016/j.midw.2006.02.003. Epub 2006 Oct 18.
Related Links
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Karlstad University Webb page
Other Identifiers
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84839
Identifier Type: -
Identifier Source: org_study_id