Improving identification and treatment of postpartum mastitis
Official title: OPTIMISTOptimizing Mastitis Identification and Treatment
Run by University of Tromso · NCT05794945 · Data updated 2026-11-12
This study is trying to learn more about postpartum mastitis in breastfeeding women to improve treatment and guidelines, especially around the use of antibiotics.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | University of Tromso Academic / other |
| Locations | 2 sites (Tromsø, Troms and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2028 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT05794945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant mothers over 18 who can understand information in Norwegian or English and are willing to participate in questionnaires and provide biological samples.
✕Probably not a fit
Patients who are not pregnant or do not meet the language comprehension requirements may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather information on the causes and progression of postpartum mastitis to develop evidence-based clinical guidelines and treatment plans, particularly regarding antibiotic use. Researchers will compare breastfeeding women with and without mastitis to analyze differences in microbial composition in milk and on the skin. The study will also investigate whether clinical symptoms differ between inflammatory and infectious mastitis and explore the impact of antibiotic treatment on bacterial composition. By collecting milk samples and questionnaires, the study seeks to fill existing knowledge gaps in mastitis management.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment and prevention strategies for postpartum mastitis, benefiting breastfeeding mothers and their infants.
How similar studies have gone: While there is ongoing research into mastitis, this study's specific approach to examining microbial composition and its relationship to mastitis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant mothers aged \> 18 * mothers must understand information given in Norwegian or English * participants must be willing to complete study questionnaires * participants must be willing to and provide biological samples Exclusion Criteria: * No exclusion criteria
Where it's running
-
Tromsø municipality, health centre
Tromsø, Troms, Norway Recruiting -
UiT-The Arctic University of Norway
Tromsø, Norway Recruiting
Study contacts
- Principal investigator: Jorunn Pauline Cavanagh, PhD — The Arctic university of Norway-UiT
- Study coordinator: Jorunn Pauline Cavanagh, PhD
- Email: pauline.cavanagh@uit.no
- Phone: 40498490
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.