Examining and measuring the pelvic veins on transvaginal ultrasound

ISRCTN ISRCTN48651822
DOI https://doi.org/10.1186/ISRCTN48651822
IRAS number 156669
Secondary identifying numbers 14/WM/1266, IRAS 156669
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Tejal Amin
Scientific

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

ORCiD logoORCID ID 0000-0001-5827-3405
Phone +44 (0)8451555000
Email tejal.amin@nhs.net

Study information

Study designObservational cross sectional
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAssessment of the uterine venous plexus
Study objectivesThe 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) studiedPelvic pain
InterventionWomen 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 typeProcedure/Surgery
Primary outcome measure1.Diameter of pelvic vein measured during transvaginal ultrasound. The diameter is measured from a frozen image of the vein on the ultrasound machine
2. Pain is measured using the visual analogue score (VAS) at the initial appointment
Secondary outcome measuresMeasured at the initial appointment
1. Proportion of women with normal pelvic organs measured using transvaginal ultrasound
2. Proportion of women with evidence of uterine/ovarian pathology measured using transvaginal ultrasound
3. Proportion of women with pelvic pain and/or heavy periods presenting to the gynaecology clinic measured using using the pictorial blood assessment chart (PBAC)
Overall study start date01/01/2015
Completion date31/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants1,500
Total final enrolment1500
Key inclusion criteria1. Age > 18 years
2. Ability to undergo a transvaginal ultrasound scan
3. No previous history of hysterectomy
4. Sign written consent form
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/08/2015
Date of final enrolment31/12/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College Hospital
Department of Obstetrics and Gynaecology
250 Euston Road
London
NW1 6BU
United Kingdom

Sponsor information

University College London
University/education

Joint Research office
Gower Street
London
WC1E 6BT
England
United Kingdom

Phone +44 (0)2034474430
Email suzanne.emerton@ucl.ac.uk
Website http://www.ucl.ac.uk
ROR logo "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 date13/07/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planWe are intending to publish the study in an international peer reviewed journal
IPD sharing planAll 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?
Protocol file version v3 14/10/2018 07/08/2020 No No
HRA research summary 28/06/2023 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.