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Completed

NCT Number: NCT04655144

Dexamethasone for Post Uterine Artery Embolization Pain

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.

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Key information

Conditions

Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone delivered to the uterine arterial bed, prior to embolization.

Saline

Drug

Saline delivered to the uterine arterial bed, prior to embolization.

Primary outcomes

  1. Pain Scores Using the VAS Questionnaire

    Time frame: 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 outcomes

  1. Severity of Post-embolization Syndrome Symptoms

    Time frame: 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

    • - 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.

  2. Change in Symptoms

    Time frame: 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:

    • 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.

  3. Change in Quality of Life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: Dex-Fib

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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