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
136 participants
OBSERVATIONAL
2006-12-31
2009-12-31
Brief Summary
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Detailed Description
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The diagnosis of candida infection in breastfeeding women is generally based on signs and symptoms identified in case reports and without any culture. Breastfeeding pain has been described as superficial or deep in some studies. This deep pain syndrome as caused by candida or bacteria has been questioned. A few studies have cultured breast milk from women with deep breast pain and found Candida albicans infections or bacterial infections usually caused by Staphylococcus aureus. There still remains controversy and lack of evidence for candidiasis affecting the lactating breast as well as bacteria causing the pain. Ensured diagnostic methods are important due to the resistant problem with both antibiotics and antifungals. Only one study has described five key symptoms associated with candida. It was shiny, flaky nipple/areola, burning pain on the nipple/areola, non-stabbing pain or stabbing pain in the breast.
The objective of this study was to investigate the prevalence of candida and bacteria in women with superficial or deep breastfeeding pain and to identify signs and symptoms linked to candida or bacteria in breast milk and nipple/areola.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1. Deep pain group
1\. Deep pain group; Pain in the breast
No interventions assigned to this group
2. Superficial pain group
Pain on the nipple and/or aereola
No interventions assigned to this group
3. Control group
No pain or other breastfeeding problems
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* clinical signs of mastitis
* muscular pain
* breast surgery
* use of antibiotic or antifungal treatment during the last preceding week
* temperature \> = 37 degree Celsius
18 Years
FEMALE
Yes
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Marie Berg, PhD,MPH,MNS
Role: STUDY_DIRECTOR
Sahlgrenska Academy at University of Gothenburg
Other Identifiers
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PainBreastfeed
Identifier Type: -
Identifier Source: org_study_id