Examining and measuring the pelvic veins on transvaginal ultrasound
| ISRCTN | ISRCTN48651822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48651822 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 156669 |
| Protocol serial number | 14/WM/1266, IRAS 156669 |
| Sponsor | University College London |
| Funder | University College London |
- Submission date
- 13/07/2020
- Registration date
- 20/07/2020
- Last edited
- 07/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Pelvic pain is a common presenting symptom to the gynaecology clinic and can have a negative impact on the overall quality of life. Pelvic venous congestion is thought to be a potential cause of pelvic pain. This involves dilatation of the pelvic veins. The uterine veins are large vessels in the pelvis that supply the uterus and ovaries, and can be seen on transvaginal ultrasound. Previous studies have demonstrated that dilatation of these veins can lead to pelvic pain but there have been no studies that look at what the normal diameter of the uterine vein is and what other factors can cause them to dilate. The main aim of our study is to measure the uterine veins and see what can lead to their dilatation. The second aim is to see if it is linked to pelvic pain and other common gynaecological symptoms.
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 standard examination of the pelvic organs, we will examine the pelvic veins and take measurements of the diameter. This will not impact or change their care or management.
What are the possible benefits and risks of participating?
The benefits of participating are that dilated uterine veins may trigger symptoms that prompt women to be referred to gynaecology clinics. By examining the uterine veins, we will be able to see if they contribute to common symptoms such as pelvic pain, heavy/irregular bleeding. This will then allow clinicians to offer appropriate treatment. As the examination is part of the routine assessment, there are no additional risks.
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 Tejal Amin
tejal.amin@nhs.net
Contact information
Scientific
Institute for Women's Health
250 Euston Road
London
NW1 6BU
United Kingdom
 ORCID ID |
0000-0001-5827-3405 |
|---|---|
| Phone | +44 (0)8451555000 |
| tejal.amin@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Assessment of the uterine venous plexus |
| Study objectives | The uterine pelvic venous plexus can be examined in all women and will differ depending on demographics and presence of pathology |
| Ethics approval(s) | Approved 16/12/2014, West Midlands-Solihull HRA REC (Education Centre, Solihull Hospital, Lode Lane, Solihull, B91 2JL, UK; +44 (0)2071048104; NRESCommittee.WestMidlands-Solihull@nhs.net), ref: 14/WM/1266 |
| Health condition(s) or problem(s) studied | Pelvic pain |
| Intervention | Women who are referred to the gynaecology clinic all have a pelvic ultrasound (transvaginal if tolerated) as part of their routine clinical appointment. Before their scan, they will be asked if their information can be used as part of the study looking at pelvic veins, which is also part of the ultrasound examination. If they agree, they are asked to sign a consent form before the examination. The ultrasound examination usually takes 5-15 minutes, depending on complexity of the findings. The women will be managed depending on their presenting symptoms and ultrasound findings. The measurements of the pelvic veins are an observation and do not affect or contribute to the overall management of the woman. Women will have follow up appointments if the scan or presenting symptoms require further monitoring. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1.Diameter of pelvic vein measured during transvaginal ultrasound. The diameter is measured from a frozen image of the vein on the ultrasound machine |
| Key secondary outcome measure(s) |
Measured at the initial appointment |
| 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 | 1500 |
| Total final enrolment | 1500 |
| Key inclusion criteria | 1. Age > 18 years 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 | 01/08/2015 |
| 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version v3 | 14/10/2018 | 07/08/2020 | No | No |
Additional files
- ISRCTN48651822 _PROTOCOL_v3_14Oct2018.pdf
- uploaded 07/08/2020
Editorial Notes
07/08/2020: Uploaded protocol (not peer reviewed) Version 3 14 October 2018.
20/07/2020: Trial’s existence confirmed by West Midlands-Solihull HRA REC.
