Dexamethasone for Post Uterine Artery Embolization Pain (Dex-Fib)

University of Miami

Status and phase: Active, not recruiting; Phase 3

Conditions: Leiomyoma

Treatments: Drug: Dexamethasone; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04655144

20200788

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

Dexamethasone Arm

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Saline Arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline