Dexamethasone for Post Uterine Artery Embolization Pain

Phase 3

Active, not recruiting

• 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
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 82

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) symptomatology will be assessed using a PES survey
Change in symptoms	Baseline, 3 months	Change in participant symptoms will be assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 8-40 with the higher score indicating a patient-perceived improvement in symptomatology.
Change in quality of life	Baseline, 3 months	Change in participant quality of life will be reported 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 best positive response.
Change in uterine fibroid volume	Baseline, 3 months	As evaluated via magnetic Resonance Imaging (MRI) using volumetric software

Trial Locations

Locations (1)

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