Use of Dexamethasone in Uterine Artery Embolization
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ClinicalTrials.gov Identifier: NCT02056717 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : April 17, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Myoma Adenomyosis | Drug: Dexamethasone Drug: Normal saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Dexamethasone group |
Drug: Dexamethasone
Administration of dexamethasone 10 mg IV 1 h before UAE |
Placebo Comparator: Control group |
Drug: Normal saline
Administration of normal saline 2 mL IV 1 h before UAE |
- 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
- Pain [ Time Frame: 24 hours ]Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
- Nausea and vomiting [ Time Frame: 24 hours ]Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
- Sucessful rate at 3 month after UAE [ Time Frame: 3 month ]Utrerine volume and complete necrosis incidence

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056717
Korea, Republic of | |
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine | |
Seoul, Korea, Republic of |
Responsible Party: | So Yeon Kim, Assistant professor, Severance Hospital |
ClinicalTrials.gov Identifier: | NCT02056717 |
Other Study ID Numbers: |
4-2013-0863 |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | April 17, 2015 |
Last Verified: | April 2015 |
Leiomyoma Myofibroma Adenomyosis Uterine Diseases Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Dexamethasone |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |