Plain English Summary
Background and study aims
Clots in the veins are an important health problem. Recent studies have shown that the proportion of women attending for a gynaecological ultrasound scan have evidence of asymptomatic clots in their pelvic veins. This is a new finding and the significance is unknown. The main aim of our study is to see how common these asymptomatic clots are in women attending gynaecological outpatient clinics. We also plan to look at what happens to them over time, how and why they develop.
Who can participate?
We are planning to recruit women who are referred to our gynaecological outpatient department for ultrasound scans.
What does the study involve?
In all women, in addition to the stranded examination of the pelvic organs, we will examine the pelvic veins and look for the signs of clots. Those with evidence of blood clots in the pelvic veins will be offered a blood test to check their clotting. Women with abnormal results will then be referred to haematologist (doctors that specialise in blood clotting disorders). Those with normal blood results will be followed up at one, three, and six months following the initial diagnosis or until the clot has resolved on the scan. Women with persistent clots after six months of follow up will also be offered haematological assessment and advice.
What are the possible benefits and risks of participating?
The diagnosis of pelvic vein thrombosis will trigger more detailed investigations including blood tests to identify women who are at risk of developing blood clots in other parts of the body. This would help us to offer them preventative measures to reduce their risk of developing potentially serious complications such as blood clots travelling to the lungs and causing problems with circulation and breathing. The possible risks are that the diagnosis of a uterine vein thrombus may cause anxiety and repeated tests to see whether they have cleared naturally or following the treatment.
Where is the study run from?
Department of Obstetrics and Gynaecology, University College Hospital, UK.
When is the study starting and how long is it expected to run for?
April 2015 to December 2016
Who is funding the study?
University College London, UK.
Who is the main contact?
Ms Davor Jurkovic
davor.jurkovic@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Ms Davor Jurkovic
ORCID ID
http://orcid.org/0000-0001-6487-5736
Contact details
Institute for Women's Health
250 Euston Road
London
NW1 6BU
United Kingdom
08451555000
davor.jurkovic@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
14/WM/1266
Study information
Scientific title
The prevalence of incidental uterine venous plexus thrombosis in women attending a gynaecology clinic: A prospective study
Acronym
Study hypothesis
We hypothesise that uterine vein thrombosis is common
Ethics approval
Approved 16/12/2014, West Midlands-Solihull HRA REC (Education Centre, Solihull Hospital, Lode Lane, Solihull, B91 2JL; NRESCommittee.WestMidlands-Solihull@nhs.net; 02071048104), ref: 14/WM/1266
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Deep vein thrombosis
Intervention
All women underwent a transvaginal ultrasound examination by a single operator. All women who were diagnosed with pelvic vein thrombosis underwent a thrombophilia screen and bilateral lower limb venous duplex scanning.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Prevalence of uterine venous plexus thrombosis measured by observation of a transvaginal ultrasound examination
Secondary outcome measures
1. Proportion of women with uterine venous plexus thrombosis with positive thrombophilia screen measured using blood test
2. Proportion of women with uterine venous plexus thrombosis with concomitant leg deep vein thrombosis measured using venous duplex scanning
Overall trial start date
01/01/2015
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >18
2. Ability to undergo a transvaginal ultrasound scan
3. No previous history of hysterectomy
4. Sign written consent form
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1298
Total final enrolment
1298
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2015
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Obstetrics and Gynaecology
University College Hospital
250 Euston Road
London
NW1 6BU
United Kingdom
Sponsor information
Organisation
Joint Research Office
Sponsor details
University College London
Gower Street
London
WC1E 6BT
United Kingdom
02034474430
suzanne.emerton@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University College London
Alternative name(s)
UCL
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We are intending to publish the study in an international peer reviewed journal
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/09/2019
Participant level data
Other
Basic results (scientific)
Publication list