Clinical trial NCT01631461: Painful Breastfeeding and Bacterial or Yeast Infection
Official title: The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Infection
Keywords: pain
breast feeding
yeast
candida albicance
staphylococcus aureus
Signs and symptoms
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2012-06-29
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Bacteria
timeFrame: Baseline (at admission)
measure: Yeast
timeFrame: Baseline (at admission)
Secondary outcomes:
measure: Pain
timeFrame: Baseline (at admission)
measure: Signs
timeFrame: Baseline (at admission)
measure: Bacteria at follow-up
timeFrame: 2 weeks after baseline
measure: Yeast at follow-up
timeFrame: 2 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Sahlgrenska Academy at University of Gothenburg
name: Marie Berg, PhD,MPH,MNS
role: STUDY_DIRECTOR
References: