Varicose VeinsNCT05058989
The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
An observational study of Varicose Veins and Varicose Veins of Lower Limb, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Varicose veins (VV) are the early sign of Chronic venous insufficiency (CVI) which are characterised by abnormal tortuosity and dilatation of superficial veins of lower limb extremities. Factors for the development of VV exist in literature. However, the exact mechanism remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins, Varicose Veins of Lower Limb, Chronic Venous Insufficiency
- What is being tested?
- Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI) and Clinical interventions and procedures
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in their first trimester who are willing to be followed up for 1 year and agreeing to give the informed consent will be included in the inclusion criteria.
Who may be able to join
- Patients who are willing to be followed up for 1 year and agreeing to give the informed consent will be included in the inclusion criteria.
Who cannot join
- Any incomplete cases such as intrauterine death.
- Participants who fail to attend the scans after their first visit will be excluded.
- Patients with congenital vascular abnormalities/syndromes such as Klippel Klippel-Trenaunay syndrome.
- Patients who are unable to provide consent.
- Anyone who are taking part in any other research.
- Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs.
- Patients with signs of acute deep vein thrombosis.
- Patient suffered from severe injury of their great-saphenous vein
Trial locations and contacts
1 site in 1 country.
About this study
Varicose veins (VV) are the early sign of Chronic venous insufficiency (CVI) which are characterised by abnormal tortuosity and dilatation of superficial veins of lower limb extremities. Factors for the development of VV exist in literature. However, the exact mechanism remains unclear. The prevalence of VV are greater in women compared to men and also higher in pregnant women compared to non-pregnant women which make pregnant women at higher risk of developing VV. Furthermore, complications of VV have negative impacts on patients' quality of life and health care budget. Therefore, better understanding of the cause of VV can contribute in better quality of life to the patient and provide valuable insights to help in reducing health care cost. The present study will investigate the contribution of both mechanical and chemical factors in pregnant women by taking blood samples for genomic testing, using Duplex ultrasound, vector flow imaging, limb volume assessment using Truncated cone tool, assessment of iliac vein compression using Photoplethysmography (PPG) technique, hormonal blood test and assessing patient's quality of life using Aberdeen Varicose Veins Questionnaire (AVVQ).
Read the detailed description
Initially, patients will be approached by a member of the direct care team in the Maternity outpatients' departments in the following hospitals: West Middlesex hospital, Queen Charlotte's and Chelsea hospital and St Mary's hospital. This will be managed by experienced research professionals in the area of vascular surgery. If a patient is prepared to discuss their potential role in this research, then the researchers will discuss the study and recruitment details at the patient's convenience. Recruitment is completely voluntary and will not affect their routine care, this will be made clear during the discussion regarding the research, and again during the consenting process. Time will be made available for any questions and for the patient to consider recruitment in their own time. Patients will be required to consent before any study-related procedures are carried out. Then her personal identifiable data will be coded and pseudonymised.
The recruited patient will be interviewed to obtain clinical information that is essential for robust analysis. This clinical information will include standard demographic form which will be used for all patients in each follow up in order to record and gather important information which represents the composition of the target population. Gathered data will include patients' details; patients name, day of visit, hospital name, ID number, date of birth. Furthermore, this demographic form will record potential risk factors which may associate with VV development such as race, number of pregnancies, family history of venous disease, BMI which include weight and height, occupational factors, smoking, alcohol consumption and diet. Any complications arising from pregnancy will be also recorded. Finally, this proposed study will only record fetal weight in second and third trimester to correlate increased fetal weight with potential venous pathology.
First, patients will be asked to fill the demographic form then will be asked to stand on a scale to measure the weight. Height will be recorded by bringing the horizontal measure down to rest on the top of the participants head. Following this, patient will be asked to sit while measurements are recorded in a relevant source data sheet.
Next, the patient will be asked to stand on a step facing the sonographer to assess the incidence of varicose veins using Duplex ultrasound (DUS) and vector flow imaging (VFI). While patient is standing, Truncated cone tool will be performed immediately by measuring leg circumferences in each segments of each limb to produce accurate measurements of lower limbs volume. Following this, patient will be asked to sit on a chair for perform Iliac vein compression test (venous outflow function) using photoplethysmography (PPG) technique. Finally, patient's quality of life assessment will be evaluated by using Aberdeen Varicose Veins Questionnaire (AVVQ) check list. Thereafter, the patient will be thanked for their participation and excused.
Clinical Laboratory tests will be managed and performed by experienced research professionals in the area of vascular surgery. Four appointments will be arranged for each patient to investigate DNA genomic testing and Estriol (E3) and progesterone hormonal testing. First appointment during first trimester will include both genomic DNA and hormonal blood tests. The three remaining appointments in the second trimester, third trimester and three months after giving birth will include hormonal blood samples only. Patients will be entitled to exit the study at any time without providing a reason, this is clearly stated on our information sheet and consent form. Verbal consent will be requested before all follow-up ultrasound scans.
Researchers will ensure that demographic data, ultrasound data, lower limb volume and iliac vein compression measurements, histopathological results and quality of life assessment results will be collected and stored in such a way that confidentiality is preserved. All data will be pseudonyms by replacing names with research codes and by keeping any identifying information separate from the main dataset.
The data will be analysed with the help of the Imperial College statistics department. The results of this study may be presented at local, national or international meetings or submitted for publication in a peer-reviewed journal. From a patient's perspective, all data will be pseudonyms before the statistical analysis phase of the study and plans to publish the results of the study are made clear in our patient information sheet.
Data and all appropriate documentation will be stored for a minimum of 10 years after the completion of the study, including the follow-up period.
- Conditions
- Varicose Veins, Varicose Veins of Lower Limb, Chronic Venous Insufficiency, Varicose; Vessel
- Being tested
- Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI), Clinical interventions and procedures
- Keywords
- CVI, VV
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI)Diagnostic test
Also called photoplethysmography (PPG) technique
PPG is a non-invasive method used to evaluates the severity venous reflux by measuring the venous refiling time (VRT).The principal of PPG works by using a small light source and a photoelectric cell attached to the skin in the medial supramalleolar area of the leg (the distal lower medial area of the leg).
Clinical interventions and proceduresOther
First trimester (0-13 weeks):
- Consent
- Clinical data collection
- Blood samples (genomic+ hormonal)
- Duplex ultrasound
- Vector flow imaging (advanced ultrasound software)
- Truncated cone tool (measuring leg circumference using a tape measure)
- PPG
- AVVQ (Aberdeen varicose veins questionaire)
Second trimester (14-26 weeks):
- Clinical data collection
- Blood sample (hormonal only)
- DUS
- VFI
- Truncated cone tool
- PPG
- AVVQ
Third trimester (27-40 weeks):
Same as second trimester
Three months after giving birth:
Same as second trimester
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women who are aged between 18 to 47 years old (childbearing age). | These patients must be willing to be followed up for 1 year and agreeing to give the informed consent. Recruitment period will take up to three months. Follow up period will be conducted at the end of first, second and third trimester and three months after giving birth. Receives: Diagnostic Test: Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI); Other: Clinical interventions and procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Duplex ultrasound parameters.
Blood vein has to be patent to exclude blood clots, blood flow direction has to be antegrade to exclude backward flow (reflux) and peak reflux velocity has to be less than 0.5 seconds to be considered normal.
Measured: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Secondary outcomes (6)
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Vector flow imaging.
Blood vein has to be patent to exclude blood clots, blood flow direction has to be antegrade to exclude backward flow (reflux) and peak reflux velocity has to be less than 0.5 seconds to be considered normal.
Measured: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Measuring the lower limb volume by Truncated cone tool.
Measuring legs circumferences at two points C1 and C2 and the height between them (H) and then applying an equation.
Measured: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Measuring the iliac vein compression using the PPG technique.
This technique measures the severity of venous reflux by measuring Venous refiling time (VRT) , (Abnormal less than 20 sec).
Measured: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Genomic blood test
Using a blood sample to assess the patient DNA (to analyze genes that associate with the development of varicose veins ) and correlating these findings with the UK biobank study.
Measured: Through study completion, an average of 1 year.
Hormonal blood test
Using a blood sample to assess two hormones (Estriol (E3) and progesterone serum levels.
Measured: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
The impact of varicose veins on the patient quality of life
Patient's quality of life will be measured using Aberdeen varicose vein questionaire (AVVQ).
Measured: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Jun 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Aslam, PhD, Study director, Academic Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058989
- Sponsor's protocol ID
- 20HH5790
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ismail L, Normahani P, Standfield NJ, Jaffer U. A systematic review and meta-analysis of the risk for development of varicose veins in women with a history of pregnancy. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):518-524.e1. doi: 10.1016/j.jvsv.2016.06.003. Epub 2016 Aug 4.
PubMed 27639009Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70.
PubMed 7822904Fukaya E, Flores AM, Lindholm D, Gustafsson S, Zanetti D, Ingelsson E, Leeper NJ. Clinical and Genetic Determinants of Varicose Veins. Circulation. 2018 Dec 18;138(25):2869-2880. doi: 10.1161/CIRCULATIONAHA.118.035584.
PubMed 30566020
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
- ClinicalTrials.gov ID
- NCT05058989
- Acronym / sponsor ID
- 20HH5790
- Conditions
- Varicose Veins, Varicose Veins of Lower Limb, Chronic Venous Insufficiency, Varicose; Vessel
- Keywords
- CVI, VV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Varicose veins (VV) are the early sign of Chronic venous insufficiency (CVI) which are characterised by abnormal tortuosity and dilatation of superficial veins of lower limb extremities. Factors for the development of VV exist in literature. However, the exact mechanism remains unclear. The prevalence of VV are greater in women compared to men and also higher in pregnant women compared to non-pregnant women which make pregnant women at higher risk of developing VV. Furthermore, complications of VV have negative impacts on patients' quality of life and health care budget. Therefore, better understanding of the cause of VV can contribute in better quality of life to the patient and provide valuable insights to help in reducing health care cost. The present study will investigate the contribution of both mechanical and chemical factors in pregnant women by taking blood samples for genomic testing, using Duplex ultrasound, vector flow imaging, limb volume assessment using Truncated cone tool, assessment of iliac vein compression using Photoplethysmography (PPG) technique, hormonal blood test and assessing patient's quality of life using Aberdeen Varicose Veins Questionnaire (AVVQ).
Detailed description
Initially, patients will be approached by a member of the direct care team in the Maternity outpatients' departments in the following hospitals: West Middlesex hospital, Queen Charlotte's and Chelsea hospital and St Mary's hospital. This will be managed by experienced research professionals in the area of vascular surgery. If a patient is prepared to discuss their potential role in this research, then the researchers will discuss the study and recruitment details at the patient's convenience. Recruitment is completely voluntary and will not affect their routine care, this will be made clear during the discussion regarding the research, and again during the consenting process. Time will be made available for any questions and for the patient to consider recruitment in their own time. Patients will be required to consent before any study-related procedures are carried out. Then her personal identifiable data will be coded and pseudonymised.
The recruited patient will be interviewed to obtain clinical information that is essential for robust analysis. This clinical information will include standard demographic form which will be used for all patients in each follow up in order to record and gather important information which represents the composition of the target population. Gathered data will include patients' details; patients name, day of visit, hospital name, ID number, date of birth. Furthermore, this demographic form will record potential risk factors which may associate with VV development such as race, number of pregnancies, family history of venous disease, BMI which include weight and height, occupational factors, smoking, alcohol consumption and diet. Any complications arising from pregnancy will be also recorded. Finally, this proposed study will only record fetal weight in second and third trimester to correlate increased fetal weight with potential venous pathology.
First, patients will be asked to fill the demographic form then will be asked to stand on a scale to measure the weight. Height will be recorded by bringing the horizontal measure down to rest on the top of the participants head. Following this, patient will be asked to sit while measurements are recorded in a relevant source data sheet.
Next, the patient will be asked to stand on a step facing the sonographer to assess the incidence of varicose veins using Duplex ultrasound (DUS) and vector flow imaging (VFI). While patient is standing, Truncated cone tool will be performed immediately by measuring leg circumferences in each segments of each limb to produce accurate measurements of lower limbs volume. Following this, patient will be asked to sit on a chair for perform Iliac vein compression test (venous outflow function) using photoplethysmography (PPG) technique. Finally, patient's quality of life assessment will be evaluated by using Aberdeen Varicose Veins Questionnaire (AVVQ) check list. Thereafter, the patient will be thanked for their participation and excused.
Clinical Laboratory tests will be managed and performed by experienced research professionals in the area of vascular surgery. Four appointments will be arranged for each patient to investigate DNA genomic testing and Estriol (E3) and progesterone hormonal testing. First appointment during first trimester will include both genomic DNA and hormonal blood tests. The three remaining appointments in the second trimester, third trimester and three months after giving birth will include hormonal blood samples only. Patients will be entitled to exit the study at any time without providing a reason, this is clearly stated on our information sheet and consent form. Verbal consent will be requested before all follow-up ultrasound scans.
Researchers will ensure that demographic data, ultrasound data, lower limb volume and iliac vein compression measurements, histopathological results and quality of life assessment results will be collected and stored in such a way that confidentiality is preserved. All data will be pseudonyms by replacing names with research codes and by keeping any identifying information separate from the main dataset.
The data will be analysed with the help of the Imperial College statistics department. The results of this study may be presented at local, national or international meetings or submitted for publication in a peer-reviewed journal. From a patient's perspective, all data will be pseudonyms before the statistical analysis phase of the study and plans to publish the results of the study are made clear in our patient information sheet.
Data and all appropriate documentation will be stored for a minimum of 10 years after the completion of the study, including the follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who are aged between 18 to 47 years old (childbearing age). | – | Diagnostic Test: Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI), Other: Clinical interventions and proceduresThese patients must be willing to be followed up for 1 year and agreeing to give the informed consent. Recruitment period will take up to three months. Follow up period will be conducted at the end of first, second and third trimester and three months after giving birth. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in their first trimester who are willing to be followed up for 1 year and agreeing to give the informed consent will be included in the inclusion criteria.
Key inclusion criteria (1 listed)
- Patients who are willing to be followed up for 1 year and agreeing to give the informed consent will be included in the inclusion criteria.
Key exclusion criteria (8 listed)
- Any incomplete cases such as intrauterine death.
- Participants who fail to attend the scans after their first visit will be excluded.
- Patients with congenital vascular abnormalities/syndromes such as Klippel Klippel-Trenaunay syndrome.
- Patients who are unable to provide consent.
- Anyone who are taking part in any other research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI)Also: photoplethysmography (PPG) techniquePPG is a non-invasive method used to evaluates the severity venous reflux by measuring the venous refiling time (VRT).The principal of PPG works by using a small light source and a photoelectric cell attached to the skin in the medial supramalleolar area of the leg (the distal lower medial area of the leg). | Diagnostic test | Pregnant women who are aged between 18 to 47 years old (childbearing age). |
| Clinical interventions and proceduresFirst trimester (0-13 weeks): * Consent * Clinical data collection * Blood samples (genomic+ hormonal) * Duplex ultrasound * Vector flow imaging (advanced ultrasound software) * Truncated cone tool (measuring leg circumference using a tape measure) * PPG * AVVQ (Aberdeen varicose veins questionaire) Second trimester (14-26 weeks): * Clinical data collection * Blood sample (hormonal only) * DUS * VFI * Truncated cone tool * PPG * AVVQ Third trimester (27-40 weeks): Same as second trimester Three months after giving birth: Same as second trimester | Other | Pregnant women who are aged between 18 to 47 years old (childbearing age). |
Primary outcome
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Duplex ultrasound parameters.
Time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Blood vein has to be patent to exclude blood clots, blood flow direction has to be antegrade to exclude backward flow (reflux) and peak reflux velocity has to be less than 0.5 seconds to be considered normal.
6 secondary outcomes
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Vector flow imaging.
Time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Measuring the lower limb volume by Truncated cone tool.
Time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Measuring the iliac vein compression using the PPG technique.
Time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Genomic blood test
Time frame: Through study completion, an average of 1 year.
Hormonal blood test
Time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
The impact of varicose veins on the patient quality of life
Time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 27639009Ismail L, Normahani P, Standfield NJ, Jaffer U. A systematic review and meta-analysis of the risk for development of varicose veins in women with a history of pregnancy. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):518-524.e1. doi: 10.1016/j.jvsv.2016.06.003. Epub 2016 Aug 4.
- Background: PubMed 7822904Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70.
- Background: PubMed 30566020Fukaya E, Flores AM, Lindholm D, Gustafsson S, Zanetti D, Ingelsson E, Leeper NJ. Clinical and Genetic Determinants of Varicose Veins. Circulation. 2018 Dec 18;138(25):2869-2880. doi: 10.1161/CIRCULATIONAHA.118.035584.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Aslam, PhD study director
Academic Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Varicose Veins of Lower Limb, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Duplex ultrasound parameters. (time frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058989, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.