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Completed

NCT Number: NCT04176679

Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception

Background:

Hypervascularized products of conception remain a topic debated in terms of definitions (ultrasound criteria, need complement by angio MRI) and management. The different uterine vascular lesions are often confused. This is a recurrent problem and care are heterogeneous. The aim of the study is to evaluate the management of these entities in CHU of Montpellier and determine more homogeneous care. The investigators further aimed to evaluate clinical presentation, ultrasound criteria, complications and the gynaecological and obstetrical outcomes of patients •Methods: This study will be conducted in compliance of ethic comitee. The investigators will collect data from 64 individuals, aged 18 to 50, suffering from uterine vascular lesions associated or not with products of conception between 2013 and 2019. Caracterisitics of the population, ultrasound and angio MRI data will be collected. Management wll be described as expectative, surgery or embolization of uterine arteries and the success or not will be noted. The investigators will question patients on their gynaecologic and obstetrical outcomes by telephone.

•Discussion: The investigators aim to define and characterize the different lesions, establish ultrasound criteria that would guide treatments. Describe the current treatments and compare them in terms of efficiency and safety in order to establish a homogeneous treatment protocol in our center

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

  • data are collected by computer software and patient phone calls
  • ultrasounds criteria are reviewed by two clinicians
  • statistical analysis is realized by a independent clinician
  • the consent and agreement of the ethics committee has been sought

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women
  • Aged between 18 and 50 years
  • Managed in CHU Montpellier
  • Diagnosis of hypervascularized products of conception
  • Available ultrasound pictures

Exclusion criteria

  • Subject unable to understand the study
  • Subject with another diagnosis of bleeding
  • Subject who have retained products of conception with no vascularity or immediate curettage with uterine vacuity
  • Subject who have no available ultrasound pictures

Treatment and study plan

Primary outcomes

  1. Evolution of the effects of the selected design products Evolution of the effects of the selected design products

    Time frame: 1 day

    the incidence of retained products of conception associated with enhanced myometrial vascularity

  2. ultrasound vascularity assessment

    Time frame: 1 day

    ultrasound vascularity assessment for predicting future severe hemorrhage in retained products of conception with comparison of doppler color score (scale of the author Akiba, Kamaya and the Doppler color scoring system)

  3. compare managing of these entities

    Time frame: 1 day

    compare managing of these entities: expectative, surgery, embolization, hysteroscopy in terms of efficiency (stopping bleeding) and safety

Secondary outcomes

  1. assessment of the women quality of life

    Time frame: 1 day

    assessment of the women quality of life during managing , future fertility and pregnancy, gynaecologic healing with a telephone survey

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study

Acronym: EMV RPOC AVM

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2019
Registry last updated
Dec 13, 2019

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.