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

Completed

• Conditions: Hypervascularized Uterine Retentions

• Registration Number: NCT04176679
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2019-10-01
• Status Verified: 2019-11
• Study Completion: 2019-11-01
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
assessment of the women quality of life	1 day	assessment of the women quality of life during managing , future fertility and pregnancy, gynaecologic healing with a telephone survey

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France