Condition category
Infections and Infestations
Date applied
14/11/2016
Date assigned
30/11/2016
Last edited
30/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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 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

Phase

Drug names

Primary outcome measures

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

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 Raynauds syndrom
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

Sponsor information

Organisation

Stig & Ragna Gorthon Foundation

Sponsor details

Stortorget 16
BOX 1417
Helsingborg
25223
Sweden
+46 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 4045 78 52
info@lffs.se

Sponsor type

Charity

Website

http://www.lffs.se

Organisation

Mjölkdroppen Association

Sponsor details

Södra Vallgatan 5
Helsingborg
25187
Sweden

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Stig & Ragna Gorthon Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lions Reseach Foudation

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

Results - basic reporting

Publication summary

Publication citations

Editorial Notes