Use of Dexamethasone in Uterine Artery Embolization

April 15, 2015 updated by: So Yeon Kim, Severance Hospital

The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Drug: Normal saline
Administration of normal saline 2 mL IV 1 h before UAE
Experimental: Dexamethasone group
Drug: Dexamethasone
Administration of dexamethasone 10 mg IV 1 h before UAE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory reactions
Time Frame: 24 hours
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 6, 2014

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0863

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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