Improving identification and treatment of postpartum mastitis
OPTIMISTOptimizing Mastitis Identification and Treatment
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Tromso Academic / other |
| Locations | 2 sites (Tromsø, Troms and 1 other locations) |
| Trial ID | NCT05794945 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not pregnant or do not meet the language comprehension requirements may not benefit from this study.
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 performed: While there is ongoing research into mastitis, this study's specific approach to examining microbial composition and its relationship to mastitis is relatively novel.
Eligibility criteria
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 this trial is running
Tromsø, Troms and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.