Hypervascularized Uterine RetentionsEMV RPOC AVMNCT04176679
Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception
An observational study of Hypervascularized Uterine Retentions, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypervascularized Uterine Retentions
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2013to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women Aged between 18 and 50 years, and diagnosis of hypervascularized products of conception
Who may be able to join
- Women
- Aged between 18 and 50 years
- Managed in CHU Montpellier
- Diagnosis of hypervascularized products of conception
- Available ultrasound pictures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study
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
Read the 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
- Conditions
- Hypervascularized Uterine Retentions
- Keywords
- Women, Retained Products of conception, Arterio venous malformation, color doppler ultrasound, embolization, fertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the effects of the selected design products Evolution of the effects of the selected design products
the incidence of retained products of conception associated with enhanced myometrial vascularity
Measured: 1 day
ultrasound vascularity assessment
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)
Measured: 1 day
compare managing of these entities
compare managing of these entities: expectative, surgery, embolization, hysteroscopy in terms of efficiency (stopping bleeding) and safety
Measured: 1 day
Secondary outcomes (1)
assessment of the women quality of life
assessment of the women quality of life during managing , future fertility and pregnancy, gynaecologic healing with a telephone survey
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Sep 2013
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypervascularized Uterine RetentionsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle VINTEJOUX, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176679
- Sponsor's protocol ID
- RECHMPL19_0532
- Acronym
- EMV RPOC AVM
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception: a Retrospectif Moncentric Study
- ClinicalTrials.gov ID
- NCT04176679
- Acronym / sponsor ID
- EMV RPOC AVM / RECHMPL19_0532
- Conditions
- Hypervascularized Uterine Retentions
- Keywords
- Women, Retained Products of conception, Arterio venous malformation, color doppler ultrasound, embolization, fertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women Aged between 18 and 50 years, and diagnosis of hypervascularized products of conception
Key inclusion criteria (5 listed)
- Women
- Aged between 18 and 50 years
- Managed in CHU Montpellier
- Diagnosis of hypervascularized products of conception
- Available ultrasound pictures
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of the effects of the selected design products Evolution of the effects of the selected design products
Time frame: 1 day
the incidence of retained products of conception associated with enhanced myometrial vascularity
ultrasound vascularity assessment
Time frame: 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
Time frame: 1 day
compare managing of these entities: expectative, surgery, embolization, hysteroscopy in terms of efficiency (stopping bleeding) and safety
1 secondary outcome
assessment of the women quality of life
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle VINTEJOUX, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypervascularized Uterine Retentions, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the effects of the selected design products Evolution of the effects of the selected design products (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.