Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

Arteriovenous Malformations Clinical Trial

— MAVUFERT  

Official title:

Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656211
• Other study ID #: 35RC17_3026
• Secondary ID: 2017-A01760-53
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: August 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Uterine arteriovenous malformations (UAVM) are short circuits between systemic arterial and venous networks within the uterus. They are congenital or acquired (in the course of an endo-uterine gesture such as curettage or interventions such as caesareans or myomectomies).

They can be manifested by severe metrorrhagia that can go as far as to put the patient's vital prognosis at risk.

There are no recommendations for the management of UAVM since this pathology is rare and therefore series are performed with few cases. If some of these UAVM disappear spontaneously after a therapeutic abstention, when the clinical context allows it, in case of symptomatic UAVM, a selective embolization with arteriography is often carried out to postpone the hysterectomy of hemostasis.

There are also more marginal management options such as Gonadotropin-Releasing Hormone agonists, methotrexate or curettage that are decided on a case by case basis depending on the symptoms and protocols of each medical team.

Regarding subsequent fertility and pregnancy outcomes after conservative treatment, the number of studies is even lower.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patient

• Diagnosis of UAVM, symptomatic or not, between January 1st, 2000 and March 30th, 2017 confirmed by imagery performed at the Rennes University Hospital

• Not against her participation in research

Exclusion Criteria:

• Minor patient at the time of diagnosis

• congenital UAVM

• Uterine malformation

• Patient under legal protection (guardianship, curatorship, safeguard of justice).

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma

Intervention

Other:
• Telephone interview
Patients are contacted by telephone to know the history of the disease since the diagnosis of UAVM and the impact of management on fertility. All medical data related to the care and necessary for the study are collected from the medical file the participation of the patients is limited to a telephone interview.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes cedex

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of fertility	The telephone interview seeks to assess fertility for all patients diagnosed with symptomatic or non-symptomatic UAVM regardless of initial management.	At the time of inclusion
Secondary	Pregnancy outcomes after UAVM	The telephone interview allows to evaluate pregnancy outcomes after diagnosis of UAVM regardless of initial management, in terms of live birth (full term or preterm birth), stillbirth, spontaneous abortion, and induced abortion.	At the time of inclusion
Secondary	Term of delivery after UAVM	The telephone interview allows to evaluate the term of delivery after diagnosis of UAVM regardless of initial management	At the time of inclusion
Secondary	Side effects of treatments for UAVM	The telephone interview allows to inventory the side effects of treatments	At the time of inclusion
Secondary	Complications of treatments for UAVM	The telephone interview allows to evaluate the complications of treatments	At the time of inclusion