Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation
Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
A randomized trial which compares conservative management to progesterone based treatment for arteriovenous malformation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedAugust 8, 2022
August 1, 2022
4 months
August 4, 2022
August 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
AVM regression
The time from diagnosis to regression
3 weeks
Study Arms (2)
Conservative management
NO INTERVENTIONProgesterone treatment
EXPERIMENTALInterventions
The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.
Eligibility Criteria
You may qualify if:
- women between age of 18 to 50, diagnosed with AVM
- hemodynamically stable at clinical presentation
You may not qualify if:
- unstable patients
- contraindication to treatment
- US examination not in the US department
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
August 4, 2022
First Posted
August 8, 2022
Study Start
August 1, 2022
Primary Completion
December 1, 2022
Study Completion
January 1, 2024
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share