Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception (EMV RPOC AVM)

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

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

Study Overview

• Status: Completed
• Conditions: Hypervascularized Uterine Retentions

Detailed Description

• 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

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women Aged between 18 and 50 years, and diagnosis of hypervascularized products of conception

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the effects of the selected design products Evolution of the effects of the selected design products	the incidence of retained products of conception associated with enhanced myometrial vascularity	1 day
ultrasound vascularity assessment	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)	1 day
compare managing of these entities	compare managing of these entities: expectative, surgery, embolization, hysteroscopy in terms of efficiency (stopping bleeding) and safety	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the women quality of life	assessment of the women quality of life during managing , future fertility and pregnancy, gynaecologic healing with a telephone survey	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Emmanuelle VINTEJOUX, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Women; fertility; Retained Products of conception, Arterio venous malformation; color doppler ultrasound; embolization
• Other Study ID Numbers: RECHMPL19_0532

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No