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临床试验/NCT04176679
NCT04176679已完成不适用

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

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Evolution of the effects of the selected design products Evolution of the effects of the selected design products

研究概览

简要总结

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

详细描述

  • 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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evolution of the effects of the selected design products Evolution of the effects of the selected design products

时间窗: 1 day

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

ultrasound vascularity assessment

时间窗: 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

时间窗: 1 day

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

次要结局

  • assessment of the women quality of life(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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