Breast InfectionNCT01631461
Painful Breastfeeding and Bacterial or Yeast Infection
An observational study of Breast Infection, run by Göteborg University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Infection
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- scored pain > = VAS 4
Who cannot join
- 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
About this study
Official title: The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms
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.
Read the 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.
- Conditions
- Breast Infection
- Keywords
- pain, breast feeding, yeast, candida albicance, staphylococcus aureus, Signs and symptoms
- Medical subject headings
- Mastitis, Pain, Breast Feeding, Staphylococcal Infections, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteria
Occurrence of bacteria: yes/no
Measured: Baseline (at admission)
Yeast
Occurence of yeast: yes/no
Measured: Baseline (at admission)
Secondary outcomes (4)
Pain
VAS
Measured: Baseline (at admission)
Signs
Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting
Measured: Baseline (at admission)
Bacteria at follow-up
Occurence of bacteria: yes/no
Measured: 2 weeks after baseline
Yeast at follow-up
Occurence of yeast: yes/no
Measured: 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast InfectionStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Marie Berg, PhD,MPH,MNS, Study director, Sahlgrenska Academy at University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631461
- Sponsor's protocol ID
- PainBreastfeed
- Status last verified
- Nov 2016
- First submitted
- 12 Jun 2012
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms
- ClinicalTrials.gov ID
- NCT01631461
- Acronym / sponsor ID
- PainBreastfeed
- Conditions
- Breast Infection
- Keywords
- pain, breast feeding, yeast, candida albicance, staphylococcus aureus, Signs and symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- scored pain > = VAS 4
Key exclusion criteria (6 listed)
- breastfeeding technique problems
- clinical signs of mastitis
- muscular pain
- breast surgery
- use of antibiotic or antifungal treatment during the last preceding week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacteria
Time frame: Baseline (at admission)
Occurrence of bacteria: yes/no
Yeast
Time frame: Baseline (at admission)
Occurence of yeast: yes/no
4 secondary outcomes
Pain
Time frame: Baseline (at admission)
Signs
Time frame: Baseline (at admission)
Bacteria at follow-up
Time frame: 2 weeks after baseline
Yeast at follow-up
Time frame: 2 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Berg, PhD,MPH,MNS study director
Sahlgrenska Academy at University of Gothenburg
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Infection, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteria (time frame: Baseline (at admission)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.