NCT02056717

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

February 3, 2014

Last Update Submit

April 15, 2015

Conditions

Uterine MyomaAdenomyosis

Outcome Measures

Primary Outcomes (1)

  • Inflammatory reactions

    CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h

    24 hours

Secondary Outcomes (3)

  • Pain

    24 hours

  • Nausea and vomiting

    24 hours

  • Sucessful rate at 3 month after UAE

    3 month

Study Arms (2)

Dexamethasone group

EXPERIMENTAL
Drug: Dexamethasone

Control group

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

DexamethasoneDRUG

Administration of dexamethasone 10 mg IV 1 h before UAE

Dexamethasone group
Normal salineDRUG

Administration of normal saline 2 mL IV 1 h before UAE

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Uterine artery embolization due to multiple myoma or adenomyosis

You may not qualify if:

  • Diabetic mellitus
  • Steroid administration
  • Liver or kidney dysfuntion
  • High baseline CRP or leukocytosis (\>11,000/μL )
  • Drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

MyofibromaAdenomyosis

Interventions

DexamethasoneSaline Solution

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 6, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

KR(1)