Observation vs Progesterone Treatment for Management of Uterine Arteriovenous Malformation

Arteriovenous Malformations Clinical Trial

Official title:

Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05491343
• Other study ID #: 0060-22EMC
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2022
• Est. completion date: January 2024

Study information

• Verified date: August 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: January 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma

Intervention

Drug:
• MedroxyPROGESTERone Injection [Depo-Provera]
The drug-induced endometrial changes would likely to prevent the shedding of endometrium, in turn preventing the exposure of AVM.

Device:
• Other
Follow up using US

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AVM regression	The time from diagnosis to regression	3 weeks