Adenomyosis, Uterine Myoma
Conditions
Brief summary
The primary purpose of this study is to investigate the effects of dexamethasone on inflammatory reactions after uterine artery embolization. The secondary purpose of this study it to investigate the effects of dexamethasone on postembolization syndrome (severe pain, nasea and vomiting).
Interventions
DRUGDexamethasone
Administration of dexamethasone 10 mg IV 1 h before UAE
DRUGNormal saline
Administration of normal saline 2 mL IV 1 h before UAE
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Uterine artery embolization due to multiple myoma or adenomyosis
Exclusion criteria
* Diabetic mellitus * Steroid administration * Liver or kidney dysfuntion * High baseline CRP or leukocytosis (\>11,000/μL ) * Drug allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory reactions | 24 hours | CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea and vomiting | 24 hours | Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h |
| Sucessful rate at 3 month after UAE | 3 month | Utrerine volume and complete necrosis incidence |
| Pain | 24 hours | Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h |
Countries
South Korea
Outcome results
None listed