Trial Outcomes & Findings for Dexamethasone for Post Uterine Artery Embolization Pain (NCT NCT04655144)
NCT ID: NCT04655144
Last Updated: 2026-01-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
42 participants
Primary outcome timeframe
Day 7
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Consumed THC
|
1
|
0
|
|
Overall Study
Unilateral embolization
|
0
|
1
|
Baseline Characteristics
Dexamethasone for Post Uterine Artery Embolization Pain
Baseline characteristics by cohort
| Measure |
Dexamethasone Arm
n=21 Participants
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.
|
Saline Arm
n=21 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=37 Participants
|
21 Participants
n=56 Participants
|
42 Participants
n=95 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=37 Participants
|
21 Participants
n=56 Participants
|
42 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=37 Participants
|
9 Participants
n=56 Participants
|
16 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
11 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=37 Participants
|
8 Participants
n=56 Participants
|
15 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Day 7Pain 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).
Outcome measures
| Measure |
Dexamethasone Arm
n=20 Participants
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.
|
Saline Arm
n=20 Participants
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.
|
|---|---|---|
|
Pain Scores Using the VAS Questionnaire
2 Hours
|
5.45 score on a scale
Standard Deviation 2.9
|
5.8 score on a scale
Standard Deviation 3.1
|
|
Pain Scores Using the VAS Questionnaire
3 Hours
|
5 score on a scale
Standard Deviation 2.8
|
4.9 score on a scale
Standard Deviation 3.2
|
|
Pain Scores Using the VAS Questionnaire
6 Hours
|
4.6 score on a scale
Standard Deviation 2.5
|
5.9 score on a scale
Standard Deviation 3.2
|
|
Pain Scores Using the VAS Questionnaire
9 Hours
|
4.4 score on a scale
Standard Deviation 3.0
|
5.9 score on a scale
Standard Deviation 2.9
|
|
Pain Scores Using the VAS Questionnaire
12 Hours
|
4.3 score on a scale
Standard Deviation 3.3
|
4.5 score on a scale
Standard Deviation 3.2
|
|
Pain Scores Using the VAS Questionnaire
24 Hours
|
2.5 score on a scale
Standard Deviation 2.4
|
4.2 score on a scale
Standard Deviation 2.9
|
|
Pain Scores Using the VAS Questionnaire
48 Hours
|
2.7 score on a scale
Standard Deviation 3.2
|
5.1 score on a scale
Standard Deviation 3.0
|
|
Pain Scores Using the VAS Questionnaire
72 Hours
|
3.42 score on a scale
Standard Deviation 2.9
|
4.7 score on a scale
Standard Deviation 3.0
|
|
Pain Scores Using the VAS Questionnaire
96 Hours
|
2.35 score on a scale
Standard Deviation 2.4
|
4.5 score on a scale
Standard Deviation 3.2
|
|
Pain Scores Using the VAS Questionnaire
168 Hours
|
1.7 score on a scale
Standard Deviation 2.6
|
2.9 score on a scale
Standard Deviation 2.4
|
|
Pain Scores Using the VAS Questionnaire
Preprocedural
|
0.8 score on a scale
Standard Deviation 1.5
|
1.3 score on a scale
Standard Deviation 2.1
|
|
Pain Scores Using the VAS Questionnaire
1 Hour
|
6 score on a scale
Standard Deviation 3.3
|
6.3 score on a scale
Standard Deviation 3.2
|
|
Pain Scores Using the VAS Questionnaire
Immediate
|
4 score on a scale
Standard Deviation 3.2
|
6.1 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Day 7Post-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.
Outcome measures
| Measure |
Dexamethasone Arm
n=20 Participants
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.
|
Saline Arm
n=20 Participants
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.
|
|---|---|---|
|
Severity of Post-embolization Syndrome Symptoms
Preprocedural
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Severity of Post-embolization Syndrome Symptoms
Immediate Postprocedural
|
0.1 score on a scale
Standard Deviation 0.3
|
0.2 score on a scale
Standard Deviation 0.5
|
|
Severity of Post-embolization Syndrome Symptoms
1 Hour
|
0.3 score on a scale
Standard Deviation 0.8
|
0.4 score on a scale
Standard Deviation 0.7
|
|
Severity of Post-embolization Syndrome Symptoms
2 Hour
|
0.4 score on a scale
Standard Deviation 0.8
|
0.5 score on a scale
Standard Deviation 0.8
|
|
Severity of Post-embolization Syndrome Symptoms
3 Hour
|
0.4 score on a scale
Standard Deviation 0.8
|
0.6 score on a scale
Standard Deviation 1.0
|
|
Severity of Post-embolization Syndrome Symptoms
6 Hour
|
0.7 score on a scale
Standard Deviation 1.0
|
1.1 score on a scale
Standard Deviation 1.2
|
|
Severity of Post-embolization Syndrome Symptoms
9 Hour
|
0.8 score on a scale
Standard Deviation 1.2
|
1 score on a scale
Standard Deviation 1.2
|
|
Severity of Post-embolization Syndrome Symptoms
12 Hour
|
0.6 score on a scale
Standard Deviation 0.9
|
0.4 score on a scale
Standard Deviation 0.6
|
|
Severity of Post-embolization Syndrome Symptoms
24 Hour
|
0 score on a scale
Standard Deviation 0
|
0.2 score on a scale
Standard Deviation 0.5
|
|
Severity of Post-embolization Syndrome Symptoms
48 Hour
|
0.2 score on a scale
Standard Deviation 0.4
|
0.4 score on a scale
Standard Deviation 0.7
|
|
Severity of Post-embolization Syndrome Symptoms
72 Hour
|
0.3 score on a scale
Standard Deviation 0.7
|
0.8 score on a scale
Standard Deviation 1.1
|
|
Severity of Post-embolization Syndrome Symptoms
96 Hour
|
0.1 score on a scale
Standard Deviation 0.4
|
0.4 score on a scale
Standard Deviation 0.7
|
|
Severity of Post-embolization Syndrome Symptoms
168 Hour
|
0.2 score on a scale
Standard Deviation 0.5
|
0.1 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsThe 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.
Outcome measures
| Measure |
Dexamethasone Arm
n=20 Participants
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.
|
Saline Arm
n=20 Participants
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.
|
|---|---|---|
|
Change in Symptoms
Bleeding
|
2.4 score on a scale
Standard Deviation 1.5
|
2.3 score on a scale
Standard Deviation 1.4
|
|
Change in Symptoms
Clots
|
1.7 score on a scale
Standard Deviation 1.3
|
1.8 score on a scale
Standard Deviation 0.91
|
|
Change in Symptoms
Length
|
1.6 score on a scale
Standard Deviation 1.1
|
1.9 score on a scale
Standard Deviation 1.1
|
|
Change in Symptoms
Pain
|
1.8 score on a scale
Standard Deviation 1.2
|
2.0 score on a scale
Standard Deviation 1.2
|
|
Change in Symptoms
Nocturia
|
2.3 score on a scale
Standard Deviation 1.6
|
2.1 score on a scale
Standard Deviation 1.5
|
|
Change in Symptoms
Fluctuation
|
1.9 score on a scale
Standard Deviation 1.2
|
1.9 score on a scale
Standard Deviation 1.1
|
|
Change in Symptoms
Polyuria
|
2.3 score on a scale
Standard Deviation 1.5
|
2.2 score on a scale
Standard Deviation 1.5
|
|
Change in Symptoms
Fatigue
|
2.5 score on a scale
Standard Deviation 1.4
|
1.9 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsChange 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).
Outcome measures
| Measure |
Dexamethasone Arm
n=20 Participants
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.
|
Saline Arm
n=20 Participants
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.
|
|---|---|---|
|
Change in Quality of Life
Baseline
|
5.2 score on a scale
Standard Deviation 1.4
|
5.5 score on a scale
Standard Deviation 1.0
|
|
Change in Quality of Life
3 Month
|
2.5 score on a scale
Standard Deviation 2.0
|
1.3 score on a scale
Standard Deviation 1.8
|
Adverse Events
Dexamethasone Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Saline Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone Arm
n=21 participants at risk
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.
|
Saline Arm
n=21 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Groin hematoma
|
4.8%
1/21 • Number of events 1 • 1 year
|
4.8%
1/21 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place