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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Arm | Experimental | A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. |
|
| Saline Arm | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone delivered to the uterine arterial bed, prior to embolization. |
|
| 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 |
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasoon Mohan, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Arm | A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. Dexamethasone: Dexamethasone delivered to the uterine arterial bed, prior to embolization. |
| FG001 | 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. Saline: Saline delivered to the uterine arterial bed, prior to embolization. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone Arm | A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. Dexamethasone: Dexamethasone delivered to the uterine arterial bed, prior to embolization. |
| BG001 | Saline Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Day 7 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone Arm | A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. Dexamethasone: Dexamethasone delivered to the uterine arterial bed, prior to embolization. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin hematoma | Surgical and medical procedures | Non-systematic Assessment | Small access site groin hematomas at the right common femoral artery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prasoon Mohan, MD | Florida Interventional Institute | 305-204-7276 | contact@flinterventionalinstitute.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2023 | Jan 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Saline | Drug | Saline delivered to the uterine arterial bed, prior to embolization. |
|
| 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:
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 |
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. Saline: Saline delivered to the uterine arterial bed, prior to embolization. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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
| Posted | Mean | Standard Deviation | score on a scale | Day 7 |
|
|
|
| Secondary | 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:
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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | 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. Saline: Saline delivered to the uterine arterial bed, prior to embolization. | 0 | 21 | 0 | 21 | 1 | 21 |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 1 Hour |
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| 2 Hour |
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| 3 Hour |
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| 6 Hour |
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| 9 Hour |
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| 12 Hour |
|
| 24 Hour |
|
| 48 Hour |
|
| 72 Hour |
|
| 96 Hour |
|
| 168 Hour |
|
| Fluctuation |
|
| Length |
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| Pain |
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| Polyuria |
|
| Nocturia |
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| Fatigue |
|