Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

NCT ID: NCT03656211

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2017-10-10

Brief 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.

Conditions

Arteriovenous Malformations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with UAVM

All patients who have been diagnosed with UAVM (symptomatic or non-symptomatic) between January 1, 2000 and March 30, 2017, and confirmed by an imaging examination.

Telephone interview

Telephone interview

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krystel NYANGOH-TIMOH

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, , France

Countries

France

Other Identifiers

2017-A01760-53

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_3026

Identifier Type: -

Identifier Source: org_study_id