Dexamethasone for Post Uterine Artery Embolization Pain

Leiomyoma Clinical Trial

— Dex-Fib  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655144
• Other study ID #: 20200788
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 25, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Dexamethasone
Dexamethasone delivered to the uterine arterial bed, prior to embolization.
• Saline
Saline delivered to the uterine arterial bed, prior to embolization.

Locations

Country	Name	City	State
United States	Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of post-embolization syndrome symptoms	Post embolization Syndrome (PES) symptomatology will be assessed using a PES survey	Day 7
Secondary	Change in uterine fibroid volume	As evaluated via magnetic Resonance Imaging (MRI) using volumetric software	Baseline, 3 months
Secondary	Change in symptoms	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.	Baseline, 3 months
Secondary	Change in quality of life	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.	Baseline, 3 months