Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation (MAVUFERT)

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.

Study Overview

• Status: Completed
• Conditions: Arteriovenous Malformations
• Intervention / Treatment: Other: Telephone interview

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Rennes cedex, France, 350033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All the patients having a diagnosis of UAVM posed between January 1st, 2000 and March 30th, 2017, and confirmed by an imaging examination carried out at the Rennes University Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Side effects of treatments for UAVM	The telephone interview allows to inventory the side effects of treatments	At the time of inclusion
Complications of treatments for UAVM	The telephone interview allows to evaluate the complications of treatments	At the time of inclusion

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Krystel NYANGOH-TIMOH, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Uterine AVM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations
• Other Study ID Numbers: 35RC17_3026; 2017-A01760-53 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No