Dexamethasone for Post Uterine Artery Embolization Pain

Phase 3

Completed

• Conditions: Leiomyoma
• Interventions: Drug: Saline; Drug: Dexamethasone

• Registration Number: NCT04655144
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-07
• Study Start: 2021-01-25
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04
• Results First Submitted: 2025-05-24
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-23
• Last Update Submitted: 2025-08-23
• Results First Posted: 2025-09-12
• Last Update Posted: 2025-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Arm	Saline	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.
Dexamethasone Arm	Dexamethasone	A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.

Primary Outcome Measures

Name	Time	Method
Pain Scores Using the VAS Questionnaire	Day 7	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).

Secondary Outcome Measures

Name	Time	Method
Severity of Post-embolization Syndrome Symptoms	Day 7	Post-Embolization Syndrome (PES) was evaluated using a dedicated PES survey.; For nausea and vomiting, severity will be scored as follows: 0 - None; 1. \- Mild nausea; 2. \- Severe nausea requiring antiemetic medication; 3. \- 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.
Change in Symptoms	Baseline, 3 months	The Fibroid Symptom Score was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey. This survey evaluates eight symptoms: 1. Degree of bleeding; 2. Presence of clots; 3. Variation in the duration of periods; 4. Variation in the length of periods; 5. Pelvic pain or pressure; 6. Frequency of daytime urination; 7. Frequency of nighttime urination; 8. 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.
Change in Quality of Life	Baseline, 3 months	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).

Trial Locations

Locations (1)

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States