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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
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date June 12, 2012
First Posted Date June 29, 2012
Last Update Posted Date November 15, 2016
Study Start Date December 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2012)
  • Bacteria [ Time Frame: Baseline (at admission) ]
    Occurrence of bacteria: yes/no
  • Yeast [ Time Frame: Baseline (at admission) ]
    Occurence of yeast: yes/no
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01631461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 28, 2012)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Breast Infection
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2012)
136
Original Actual Enrollment Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01631461
Other Study ID Numbers PainBreastfeed
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Göteborg University
Study Sponsor Göteborg University
Collaborators Vastra Gotaland Region
Investigators
Study Director: Marie Berg, PhD,MPH,MNS Sahlgrenska Academy at University of Gothenburg
PRS Account Göteborg University
Verification Date November 2016