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Painful Breastfeeding and Bacterial or Yeast Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01631461
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : November 15, 2016
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
The aim of this study is to investigate the prevalence of yeast and bacteria in women with breastfeeding pain and to identify signs and symptoms.

Condition or disease
Breast Infection

Detailed Description:

Painful breastfeeding is one of the most common reasons for early weaning. Persistent pain associated with breastfeeding can sometimes be difficult to diagnose and is a source of frustration for the breastfeeding women as well as for healthcare providers.

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.

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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms
Study Start Date : December 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

1. Deep pain group
1. Deep pain group; Pain in the breast
2. Superficial pain group
Pain on the nipple and/or aereola
3. Control group
No pain or other breastfeeding problems

Primary Outcome Measures :
  1. Bacteria [ Time Frame: Baseline (at admission) ]
    Occurrence of bacteria: yes/no

  2. Yeast [ Time Frame: Baseline (at admission) ]
    Occurence of yeast: yes/no

Secondary Outcome Measures :
  1. Pain [ Time Frame: Baseline (at admission) ]

  2. Signs [ Time Frame: Baseline (at admission) ]
    Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting

  3. Bacteria at follow-up [ Time Frame: 2 weeks after baseline ]
    Occurence of bacteria: yes/no

  4. Yeast at follow-up [ Time Frame: 2 weeks after baseline ]
    Occurence of yeast: yes/no

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Group 1 and 2: Selected from the breastfeeding receptions (n=2) at Sahlgrenska University hospital and Skövde hospital Group 3, controls: Selected from Primary health care clinics

Inclusion Criteria:

  • scored pain > = VAS 4

Exclusion Criteria:

  • breastfeeding technique problems
  • clinical signs of mastitis
  • muscular pain
  • breast surgery
  • use of antibiotic or antifungal treatment during the last preceding week
  • temperature > = 37 degree Celsius

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01631461

Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
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Study Director: Marie Berg, PhD,MPH,MNS Sahlgrenska Academy at University of Gothenburg
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Responsible Party: Göteborg University Identifier: NCT01631461    
Other Study ID Numbers: PainBreastfeed
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Keywords provided by Göteborg University:
breast feeding
candida albicance
staphylococcus aureus
Signs and symptoms
Additional relevant MeSH terms:
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