Plain English Summary
Background and study aims
Breast pain during the breastfeeding period can affect mothers’ self-confidence and her motivation to continue breastfeeding. Earlier research has not given any clear answers as to whether Candida Albicans, otherwise known as “thrush”, can be the cause of breast pain. Different studies have shown varying results regarding the presence of Candida Albicans in breast milk. The aim of the present study is to examine whether women with symptoms that sound like they are related to thrush in the breast (cases) more often have Candida Albicans in their breast milk than women without these symptoms (controls). The study will examine whether women with breast pain more often cease breastfeeding than women without symptoms and whether the two groups show any difference in their confidence to breastfeed.
Who can participate?
Adult breastfeeding women over 18 years of age with and without breast pain.
What does the study involve?
All participants have samples of breast milk collected at the start of the study, which is then tested for the presence of the yeast Candida Albicans. Participants are also asked to complete a questionnaire to measure their self-confidence in breast feeding. One month later, participants are interviewed in order to find out whether they have continued breastfeeding.
What are the possible benefits and risks of participating?
There are no benefits or risks to individual women who choose to participate.
Where is the study run from?
Helsingborg Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2014 to June 2017
Who is funding the study?
1. Stig & Ragnar Gorthon Foundation (Sweden)
2. The Milk Drop Foundation (Sweden)
3. Lions Research Foundation (Sweden)
Who is the main contact?
1. Miss Kirsti Kaski (public)
kirsti.kaski@skane.se
2. Mrs Linda J. Kvist (scientific)
linda.kvist@med.lu.se
Trial website
Contact information
Type
Public
Primary contact
Miss Kirsti Kaski
ORCID ID
Contact details
BB-avdelning
Helsingborg Hospital
Charlotte Yhlens gata 10
Helsingborg
25187
Sweden
+46 (0)70 827 8604
kirsti.kaski@skane.se
Type
Scientific
Additional contact
Mrs Linda J. Kvist
ORCID ID
http://orcid.org/0000-0001-5073-2419
Contact details
Lund University
Medicinska fakultetet
Baravägen 3
Lund
22100
Sweden
+46 (0)42 227 113
linda.kvist@med.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014/600
Study information
Scientific title
A case/control study of breastfeeding women with and without symptoms that are anecdotally related to thrush in the breast. Cases and controls will be compared for presence of Candida albicans in their breast milk, premature cessation of breastfeeding and confidence in their ability to breastfeed
Acronym
Study hypothesis
Candida albicans is present in the milk of breastfeeding women who report breast pain to a higher degree than women without breast pain
Ethics approval
Central Ethical Review Board, Lund, Sweden, 16/09/2014 ref: 2014/600
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Community
Trial type
Diagnostic
Patient information sheet
See additional files (available in Swedish)
Condition
Candidosis of the breast during breastfeeding
Intervention
Participants in the case group are informed about the study when they contact the breastfeeding clinic by telephone for symptoms associated with "thrush" infection in the breasts.
Participants in the control group get information about the study and are recruited at local baby-well clinics while they have the routine health control.
One consult appointment occasion with a breastfeeding consultant is booked for the participants in the case group, inclusive usual consult appointment according the breastfeeding clinic routine.
Participants in the case group are recruited at the breastfeeding clinic after receiving more information and given a written consent. A questionnaire is used to collect information about age, parity, age of the breastfed baby, history of previous candida infections, Diabetes (gestational or type 1), type of delivery, antibiotic treatment during and after delivery, breastfeeding level (exclusive/non-exclusive), pain location and severity (NAS) and breastfeeding efficacy. Breastmilk from the most painful breast is collected for culture for Candida albicans.
Participants in the control group meet the researcher once at the baby-well clinic direct after a health control. They receive more information about the study and give their written consent. The same questionnaire as with the cases is used and breastmilk is collected for culture for Candida albicans.
Participants in the case group receive four weekly telephone contacts from a breastfeeding consult in the breastfeeding clinic. A questionnaire is used to collect information about pain severity (NAS), breastfeeding success, changes in symptoms and medicine therapy. After four weeks of telephone contacts they receive a mail questionnaire with same questions monthly in three months.
The controls receive a mail questionnaire monthly in four months with questions about breastfeeding success and if they have had symptom or pain associated with thrush in the breasts.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Presence of Candida albicans in breastmilk is measured using cultivation with Sabourad Agar or CROME Agar Candida at baseline
Secondary outcome measures
1. Breastfeeding efficacy in the breastfeeding mothers is measured by a validated breastfeeding instrument Breastfeeding Self Efficacy Scale- Short Form (BSES-SF) at baseline
2. Level of breastfeeding is measured by a questionnaire one month after the first contact with the researcher
Overall trial start date
01/01/2014
Overall trial end date
01/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Inclusion criteria for cases:
1. Breastfeeding woman
2. Adult, ≥ 18 years
3. Exclusive or non-exclusive breastfeeding
4. Good understanding of Swedish language in spoken and written form
5. One or several symptoms on the nipple and areola or in the breast: red, extenuated, tender, burning, sloughing skin on the nipple and areola, with or without deep, radiating, cutting pain sensations in the breast
Inclusion criteria for the controls:
1. Breastfeeding woman
2. Adult, ≥ 18 years
3. Exclusive or non-exclusive breastfeeding
4. Good understanding of Swedish language in spoken and written form
5. None of the symptoms on the nipple and areola or in the breast: red, extenuated, tender, burning, sloughing skin on the areola, with or without deep, radiating, cutting pain sensations in the breast
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
35 participants in each study group.
Participant exclusion criteria
1. Breastfeeding women with pain, skin symptoms or sores which can be attributed to breastfeeding technical difficulties such as short frenulum, mastitis or Raynaud's syndrome
2. Women with excema-like skin conditions and white spot
Recruitment start date
01/04/2015
Recruitment end date
01/03/2017
Locations
Countries of recruitment
Sweden
Trial participating centre
Helsingborg Hospital
Södra Vallgatan 5
Hlsingborg
25187
Sweden
Sponsor information
Organisation
Stig & Ragna Gorthon Foundation
Sponsor details
Stortorget 16
Box 1417
Helsingborg
25223
Sweden
+46 (0)42 18 33 57
info@gorthonstiftelsen.se
Sponsor type
Other
Website
http://www.gorthonstiftelsen.se/
Organisation
Lions Research Foundation, Skåne
Sponsor details
Gottåkravägen 45
Höllviken
236 41
Sweden
+46 (0)4045 78 52
info@lffs.se
Sponsor type
Charity
Website
Organisation
Mjölkdroppen Association
Sponsor details
Södra Vallgatan 5
Helsingborg
25187
Sweden
Sponsor type
Charity
Website
Organisation
Gorthonstiftelsen
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Charity
Funder name
Stig & Ragna Gorthon Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lions Research Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Mjölkdroppen Association
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The data is expected to be available after the analysis of the data has been finished.
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29977322
Publication citations
Additional files
- ISRCTN88839993_PIS_11Nov2014_ControlGroup_Swedish.docx Uploaded 30/11/2016
- ISRCTN88839993_PIS_11Nov2014_InterventionGroup_Swedish.docx Uploaded 30/11/2016