How common are pelvic blood clots in women visiting a gynaecology clinic?

ISRCTN	ISRCTN15750232
DOI	https://doi.org/10.1186/ISRCTN15750232
Secondary identifying numbers	14/WM/1266

Submission date: 15/06/2019
Registration date: 25/06/2019
Last edited: 09/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Ms Davor Jurkovic
Scientific

Institute for Women's Health
250 Euston Road
London
NW1 6BU
United Kingdom

ORCID ID	0000-0001-6487-5736
Phone	08451555000
Email	davor.jurkovic@nhs.net

Study information

Study design	Observational cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The prevalence of incidental uterine venous plexus thrombosis in women attending a gynaecology clinic: A prospective study
Study objectives	We hypothesise that uterine vein thrombosis is common
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2015
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	1298
Total final enrolment	1298
Key inclusion criteria	1. Age >18 2. Ability to undergo a transvaginal ultrasound scan 3. No previous history of hysterectomy 4. Sign written consent form
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2015
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Obstetrics and Gynaecology

University College Hospital
250 Euston Road
London
NW1 6BU
United Kingdom

Sponsor information

Joint Research Office
University/education

University College London
Gower Street
London
WC1E 6BT
England
United Kingdom

Phone	02034474430
Email	suzanne.emerton@ucl.ac.uk
Website	www.ucl.ac.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

University/education

University College London
Government organisation / Universities (academic only)

Alternative name(s): University College London in United Kingdom, Collegium Universitatis Londinensis, UCL
Location: United Kingdom

Results and Publications

Intention to publish date	01/09/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	We are intending to publish the study in an international peer reviewed journal
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	11/08/2020	09/09/2021	Yes	No
Results article	26/07/2021	09/09/2021	Yes	No
HRA research summary		28/06/2023	No	No

Editorial Notes

09/09/2021: Publication references added.
25/06/2019: Trial’s existence confirmed by West Midlands-Solihull HRA REC.