Painful Breastfeeding and Bacterial or Yeast Infection
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|ClinicalTrials.gov Identifier: NCT01631461|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : November 15, 2016
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||136 participants|
|Official Title:||The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
1. Deep pain group
1. Deep pain group; Pain in the breast
2. Superficial pain group
Pain on the nipple and/or aereola
3. Control group
No pain or other breastfeeding problems
- Bacteria [ Time Frame: Baseline (at admission) ]Occurrence of bacteria: yes/no
- Yeast [ Time Frame: Baseline (at admission) ]Occurence of yeast: yes/no
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631461
|Study Director:||Marie Berg, PhD,MPH,MNS||Sahlgrenska Academy at University of Gothenburg|