Clinical Trial: Painful Breastfeeding and Bacterial or Yeast Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms

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.

Detailed Summary:

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.

Sponsor: Göteborg University

Current Primary Outcome:

• Bacteria [ Time Frame: Baseline (at admission) ]
  Occurrence of bacteria: yes/no
• Yeast [ Time Frame: Baseline (at admission) ]
  Occurence of yeast: yes/no

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Pain [ Time Frame: Baseline (at admission) ]
  VAS
• Signs [ Time Frame: Baseline (at admission) ]
  Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting
• Bacteria at follow-up [ Time Frame: 2 weeks after baseline ]
  Occurence of bacteria: yes/no
• Yeast at follow-up [ Time Frame: 2 weeks after baseline ]
  Occurence of yeast: yes/no

Original Secondary Outcome: Same as current

Information By: Göteborg University

Dates:
Date Received: June 12, 2012
Date Started: December 2006
Date Completion:
Last Updated: November 14, 2016
Last Verified: November 2016