Painful Breastfeeding and Bacterial or Yeast Infection

Breast Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631461
• Other study ID #: PainBreastfeed
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: November 14, 2016
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Infection
• Infection
• Mastitis
• Signs and Symptoms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteria	Occurrence of bacteria: yes/no	Baseline (at admission)	Yes
Primary	Yeast	Occurence of yeast: yes/no	Baseline (at admission)	Yes
Secondary	Pain	VAS	Baseline (at admission)	Yes
Secondary	Signs	Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting	Baseline (at admission)	Yes
Secondary	Bacteria at follow-up	Occurence of bacteria: yes/no	2 weeks after baseline	Yes
Secondary	Yeast at follow-up	Occurence of yeast: yes/no	2 weeks after baseline	Yes