Painful Breastfeeding and Bacterial or Yeast Infection

Completed

• Conditions: Breast Infection

• Registration Number: NCT01631461
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacteria	Baseline (at admission)	Occurrence of bacteria: yes/no
Yeast	Baseline (at admission)	Occurence of yeast: yes/no

Secondary Outcome Measures

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