Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

Completed

• Conditions: Arteriovenous Malformations
• Interventions: Other: Telephone interview

• Registration Number: NCT03656211
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Status Verified: 2018-08
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-09-04
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with UAVM	Telephone interview	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

Primary Outcome Measures

Name	Time	Method
Evaluation of fertility	At the time of inclusion	The telephone interview seeks to assess fertility for all patients diagnosed with symptomatic or non-symptomatic UAVM regardless of initial management.

Secondary Outcome Measures

Name	Time	Method
Side effects of treatments for UAVM	At the time of inclusion	The telephone interview allows to inventory the side effects of treatments
Pregnancy outcomes after UAVM	At the time of inclusion	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.
Term of delivery after UAVM	At the time of inclusion	The telephone interview allows to evaluate the term of delivery after diagnosis of UAVM regardless of initial management
Complications of treatments for UAVM	At the time of inclusion	The telephone interview allows to evaluate the complications of treatments

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes cedex, France