Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

NCT ID: NCT05491343

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-01-31

Brief Summary

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A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation

Detailed Description

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Conditions

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Arteriovenous Malformations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative management

Group Type NO_INTERVENTION

No interventions assigned to this group

Progesterone treatment

Group Type EXPERIMENTAL

MedroxyPROGESTERone Injection [Depo-Provera]

Intervention Type DRUG

The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.

Other

Intervention Type DEVICE

Follow up using US

Interventions

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MedroxyPROGESTERone Injection [Depo-Provera]

The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.

Intervention Type DRUG

Other

Follow up using US

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* women between age of 18 to 50, diagnosed with AVM
* hemodynamically stable at clinical presentation

Exclusion Criteria

* unstable patients
* contraindication to treatment
* US examination not in the US department
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Etty Spiegel

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0060-22EMC

Identifier Type: -

Identifier Source: org_study_id

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