Condition category
Circulatory System
Date applied
15/06/2019
Date assigned
25/06/2019
Last edited
25/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.ucl.ac.uk

Funders

Funder type

University/education

Funder name

University College London

Alternative name(s)

UCL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Publication citations

Additional files

Editorial Notes

25/06/2019: Trial’s existence confirmed by West Midlands-Solihull HRA REC.