NCT05058989|Completed
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Sponsor study identifier
observational
70
1 country
1
Study Start
June 1, 2021
Actual (reported)Primary Completion
October 1, 2022
Actual (reported)Study Completion
December 1, 2022
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2021
Actual (reported)September 14, 2021
Actual (reported)September 28, 2021
Actual (reported)October 1, 2022
Actual (reported)December 1, 2022
Actual (reported)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.
1 year, in each follow up (first, second, third trimester and three months after giving birth)
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Vector flow imaging.
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.
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.
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).
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.
Imperial College London
London, W12 0HS, United Kingdom
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.
Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70.
There will be two blood samples that will be carried out for two types of analysis: 1. DNA Genomic testing. 2. Hormonal blood test (Estriol (E3) and progesterone serum). Each hormonal blood samples results including Estroil (E3) and progesterone serum levels will be correlated with the results of the next follow up to provide comprehensive information about increased hormonal levels in pregnancy and varicose veins development.
Mohammed Aslam, PhD
Academic Supervisor
70 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2021
First Posted
September 28, 2021
Study Start
June 1, 2021
Actual (reported)Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
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.
1 year, in each follow up (first, second, third trimester and three months after giving birth)
Genomic blood test
Through study completion, an average of 1 year.
Hormonal blood test
1 year, in each follow up (first, second, third trimester and three months after giving birth)
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Fukaya 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.
Primary Completion
October 1, 2022
Actual (reported)Study Completion
December 1, 2022
Actual (reported)Last Updated
October 6, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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