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Painful Breastfeeding and Bacterial or Yeast Infection

This study has been completed.
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01631461
First received: June 12, 2012
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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
"Breast Infection"

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Bacteria [ Time Frame: Baseline (at admission) ] [ Designated as safety issue: Yes ]
    Occurrence of bacteria: yes/no

  • Yeast [ Time Frame: Baseline (at admission) ] [ Designated as safety issue: Yes ]
    Occurence of yeast: yes/no


Secondary Outcome Measures:
  • Pain [ Time Frame: Baseline (at admission) ] [ Designated as safety issue: Yes ]
    VAS

  • Signs [ Time Frame: Baseline (at admission) ] [ Designated as safety issue: Yes ]
    Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting

  • Bacteria at follow-up [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: Yes ]
    Occurence of bacteria: yes/no

  • Yeast at follow-up [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: Yes ]
    Occurence of yeast: yes/no


Enrollment: 136
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631461

Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
Study Director: Marie Berg, PhD,MPH,MNS Sahlgrenska Academy at University of Gothenburg
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01631461     History of Changes
Other Study ID Numbers: PainBreastfeed
Study First Received: June 12, 2012
Last Updated: June 28, 2012
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Göteborg University:
pain
breast feeding
yeast
 candida albicance
staphylococcus aureus
Signs and symptoms

Additional relevant MeSH terms:
Signs and Symptoms
Mastitis
Puerperal Disorders
 Pregnancy Complications
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013