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Use of Dexamethasone in Uterine Artery Embolization

Primary Purpose

Uterine Myoma, Adenomyosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Normal saline
Sponsored by
Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uterine Myoma

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
Nausea and vomiting
Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
Sucessful rate at 3 month after UAE
Utrerine volume and complete necrosis incidence

Full Information

First Posted
February 3, 2014
Last Updated
April 15, 2015
Sponsor
Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02056717
Brief Title
Use of Dexamethasone in Uterine Artery Embolization
Official Title
The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma, Adenomyosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Administration of dexamethasone 10 mg IV 1 h before UAE
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Administration of normal saline 2 mL IV 1 h before UAE
Primary Outcome Measure Information:
Title
Inflammatory reactions
Description
CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain
Description
Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
Time Frame
24 hours
Title
Nausea and vomiting
Description
Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
Time Frame
24 hours
Title
Sucessful rate at 3 month after UAE
Description
Utrerine volume and complete necrosis incidence
Time Frame
3 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Use of Dexamethasone in Uterine Artery Embolization

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