Dexamethasone for Post Uterine Artery Embolization Pain (Dex-Fib)

Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization

The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.

Study Overview

• Status: Completed
• Conditions: Leiomyoma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.

Exclusion Criteria:

• Currently pregnant or actively attempting to conceive
• Those deemed mentally impaired to make their own medical decisions
• Previous documented allergy to dexamethasone
• Those currently taking daily steroids for any reason
• Those with diabetes or deemed to be pre-diabetic
• Those with contraindications for angiography
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone Arm; A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.	Drug: Dexamethasone; Dexamethasone delivered to the uterine arterial bed, prior to embolization.
Placebo Comparator: Saline Arm; A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization.	Drug: Saline; Saline delivered to the uterine arterial bed, prior to embolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores Using the VAS Questionnaire	Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain).	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Post-embolization Syndrome Symptoms	Post-Embolization Syndrome (PES) was evaluated using a dedicated PES survey. For nausea and vomiting, severity will be scored as follows: 0 - None; - Mild nausea; - Severe nausea requiring antiemetic medication; - Vomiting A score of 0 represents no symptoms (least severe), while a score of 3 represents the most severe symptoms. The scoring range is 0 to 3.	Day 7
Change in Symptoms	The Fibroid Symptom Score was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey. This survey evaluates eight symptoms: Degree of bleeding; Presence of clots; Variation in the duration of periods; Variation in the length of periods; Pelvic pain or pressure; Frequency of daytime urination; Frequency of nighttime urination; Fatigue Each symptom is scored from 1 to 5, with higher scores indicating more severe symptoms. The table below presents the mean change in score for each symptom after the intervention, compared to the pre-procedure score. Higher positive numbers indicate greater symptom improvement. In this table, the maximum possible change for an individual symptom is +4, and the minimum is -4.	Baseline, 3 months
Change in Quality of Life	Change in participant quality of life was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 0-6 with the highest score indicating the worst quality of life from fibroid symptoms and vice versa (6=Terrible and 0=Delighted).	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Prasoon Mohan, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: dexamethasone; Leiomyoma; Fibroids; post-embolization pain
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride
• Other Study ID Numbers: 20200788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No