Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tejal Amin
ORCID ID
http://orcid.org/0000-0001-5827-3405
Contact details
Institute for Women's Health
250 Euston Road
London
NW1 6BU
United Kingdom
+44 (0)8451555000
tejal.amin@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
14/WM/1266, IRAS 156669
Study information
Scientific title
Assessment of the uterine venous plexus
Acronym
Study hypothesis
The uterine pelvic venous plexus can be examined in all women and will differ depending on demographics and presence of pathology
Ethics approval
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
Study design
Observational cross sectional
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
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
Phase
Drug names
Primary outcome measure
1.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 measures
Measured 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 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 years
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
1,500
Total final enrolment
1500
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/08/2015
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College Hospital
Department of Obstetrics and Gynaecology
250 Euston Road
London
NW1 6BU
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Joint Research office
Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)2034474430
suzanne.emerton@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University College London
Alternative name(s)
UCL
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
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
13/07/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN48651822 _PROTOCOL_v3_14Oct2018.pdf uploaded 07/08/2020