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OpenTrials
Completed

NCT Number: NCT03656211

Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rennes University Hospital

Rennes, 350033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of fertility

    Time frame: 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 outcomes

  1. Pregnancy outcomes after UAVM

    Time frame: 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.

  2. Term of delivery after UAVM

    Time frame: At the time of inclusion

    The telephone interview allows to evaluate the term of delivery after diagnosis of UAVM regardless of initial management

  3. Side effects of treatments for UAVM

    Time frame: At the time of inclusion

    The telephone interview allows to inventory the side effects of treatments

  4. Complications of treatments for UAVM

    Time frame: At the time of inclusion

    The telephone interview allows to evaluate the complications of treatments

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MAVUFERT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 4, 2018
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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