Skip to main content
OpenTrials
Completed

NCT Number: NCT01631461

Painful Breastfeeding and Bacterial or Yeast Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bacteria

    Time frame: Baseline (at admission)

    Occurrence of bacteria: yes/no

  2. Yeast

    Time frame: Baseline (at admission)

    Occurence of yeast: yes/no

Secondary outcomes

  1. Pain

    Time frame: Baseline (at admission)

    VAS

  2. Signs

    Time frame: Baseline (at admission)

    Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting

  3. Bacteria at follow-up

    Time frame: 2 weeks after baseline

    Occurence of bacteria: yes/no

  4. Yeast at follow-up

    Time frame: 2 weeks after baseline

    Occurence of yeast: yes/no

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 29, 2012
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.