Condition category
Urological and Genital Diseases
Date applied
13/07/2020
Date assigned
20/07/2020
Last edited
07/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://www.ucl.ac.uk

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

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.