How common are pelvic blood clots in women visiting a gynaecology clinic?
| ISRCTN | ISRCTN15750232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15750232 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 14/WM/1266 |
| Sponsor | Joint Research Office |
| Funder | University College London |
- 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
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
Scientific
Institute for Women's Health
250 Euston Road
London
NW1 6BU
United Kingdom
 ORCID ID |
0000-0001-6487-5736 |
|---|---|
| Phone | 08451555000 |
| davor.jurkovic@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant 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(s) |
Prevalence of uterine venous plexus thrombosis measured by observation of a transvaginal ultrasound examination |
| Key secondary outcome measure(s) |
1. Proportion of women with uterine venous plexus thrombosis with positive thrombophilia screen measured using blood test |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
250 Euston Road
London
NW1 6BU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2021: Publication references added.
25/06/2019: Trial’s existence confirmed by West Midlands-Solihull HRA REC.
