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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04176679
Acronym
EMV RPOC AVM
Enrollment
64
Registered
2019-11-25
Start date
2013-09-01
Completion date
2019-11-01
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypervascularized Uterine Retentions

Keywords

Women, Retained Products of conception, Arterio venous malformation, color doppler ultrasound, embolization, fertility

Brief summary

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

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

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of the effects of the selected design products Evolution of the effects of the selected design products1 daythe incidence of retained products of conception associated with enhanced myometrial vascularity
ultrasound vascularity assessment1 dayultrasound 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)
compare managing of these entities1 daycompare managing of these entities: expectative, surgery, embolization, hysteroscopy in terms of efficiency (stopping bleeding) and safety

Secondary

MeasureTime frameDescription
assessment of the women quality of life1 dayassessment of the women quality of life during managing , future fertility and pregnancy, gynaecologic healing with a telephone survey

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026