- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01631461
Painful Breastfeeding and Bacterial or Yeast Infection
The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Bacteria
Tidsramme: Baseline (at admission)
|
Occurrence of bacteria: yes/no
|
Baseline (at admission)
|
Yeast
Tidsramme: Baseline (at admission)
|
Occurence of yeast: yes/no
|
Baseline (at admission)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain
Tidsramme: Baseline (at admission)
|
VAS
|
Baseline (at admission)
|
Signs
Tidsramme: Baseline (at admission)
|
Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting
|
Baseline (at admission)
|
Bacteria at follow-up
Tidsramme: 2 weeks after baseline
|
Occurence of bacteria: yes/no
|
2 weeks after baseline
|
Yeast at follow-up
Tidsramme: 2 weeks after baseline
|
Occurence of yeast: yes/no
|
2 weeks after baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Marie Berg, PhD,MPH,MNS, Sahlgrenska Academy at University of Gothenburg
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PainBreastfeed
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