Clinical trial NCT04176679: Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception
Official title: Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypervascularized Uterine Retentions
Keywords: Women
Retained Products of conception, Arterio venous malformation
color doppler ultrasound
embolization
fertility
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women Aged between 18 and 50 years, and diagnosis of hypervascularized products of conception

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

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the effects of the selected design products Evolution of the effects of the selected design products
timeFrame: 1 day
measure: ultrasound vascularity assessment
timeFrame: 1 day
measure: compare managing of these entities
timeFrame: 1 day
Secondary outcomes:
measure: assessment of the women quality of life
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Emmanuelle VINTEJOUX, MD
role: STUDY_DIRECTOR
References: