Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

NCT03656211 | Completed

• 2 other identifiers: 35RC17_30262017-A01760-53
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Uterine AVM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pregnancy outcomes after UAVM

  At the time of inclusion

• Term of delivery after UAVM

  At the time of inclusion

• Side effects of treatments for UAVM

  At the time of inclusion

• Complications of treatments for UAVM

  At the time of inclusion

Study Arms (1)

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

Interventions

Telephone interview 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.

Patients with UAVM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Minor patient at the time of diagnosis
• congenital UAVM
• Uterine malformation
• Patient under legal protection (guardianship, curatorship, safeguard of justice).

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 350033, France

Location

MeSH Terms

Conditions

Arteriovenous Malformations

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Krystel NYANGOH-TIMOH

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 4, 2018
• Study Start: October 2, 2017
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

FR (1)