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
The prevalence of incidental uterine venous plexus thrombosis in women attending a gynaecology clinic: A prospective study
We hypothesise that uterine vein thrombosis is common
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
Observational cross-sectional study
Primary study design
Secondary study design
Cross sectional study
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Deep vein thrombosis
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.
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
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
Total final enrolment
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Obstetrics and Gynaecology
University College Hospital 250 Euston Road
University College London
Funding Body Type
private sector organisation
Funding Body Subtype
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
Participant level data
Basic results (scientific)