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

NCT ID: NCT04176679

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2019-11-01

Brief Summary

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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

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* 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

Conditions

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Hypervascularized Uterine Retentions

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle VINTEJOUX, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uh Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL19_0532

Identifier Type: -

Identifier Source: org_study_id