Dexamethasone for Post Uterine Artery Embolization Pain

NCT ID: NCT04655144

Last Updated: 2026-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2024-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Leiomyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone Arm

A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Dexamethasone

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Prasoon Mohan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prasoon Mohan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20200788

Identifier Type: -

Identifier Source: org_study_id

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