The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
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ClinicalTrials.gov Identifier: NCT05058989 |
Recruitment Status :
Completed
First Posted : September 28, 2021
Last Update Posted : October 6, 2023
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Condition or disease | Intervention/treatment |
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Varicose Veins Varicose Veins of Lower Limb Chronic Venous Insufficiency Varicose; Vessel | Diagnostic Test: Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI) Other: Clinical interventions and procedures |
Study Type : | Observational |
Actual Enrollment : | 70 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy |
Actual Study Start Date : | June 1, 2021 |
Actual Primary Completion Date : | October 1, 2022 |
Actual Study Completion Date : | December 1, 2022 |
Group/Cohort | Intervention/treatment |
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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.
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Diagnostic Test: Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI)
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).
Other Name: photoplethysmography (PPG) technique Other: Clinical interventions and procedures First trimester (0-13 weeks):
Second trimester (14-26 weeks):
Third trimester (27-40 weeks): Same as second trimester Three months after giving birth: Same as second trimester |
- 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.
- 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) ]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.
- 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 legs circumferences at two points C1 and C2 and the height between them (H) and then applying an equation.
- 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) ]This technique measures the severity of venous reflux by measuring Venous refiling time (VRT) , (Abnormal less than 20 sec).
- Genomic blood test [ Time Frame: Through study completion, an average of 1 year. ]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.
- Hormonal blood test [ Time Frame: 1 year, in each follow up (first, second, third trimester and three months after giving birth) ]Using a blood sample to assess two hormones (Estriol (E3) and progesterone serum levels.
- 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) ]Patient's quality of life will be measured using Aberdeen varicose vein questionaire (AVVQ).
Biospecimen Retention: Samples With DNA
There will be two blood samples that will be carried out for two types of analysis:
- DNA Genomic testing.
- 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.
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Ages Eligible for Study: | 18 Years to 47 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Pregnant women |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058989
United Kingdom | |
Imperial College London | |
London, United Kingdom, W12 0HS |
Study Director: | Mohammed Aslam, PhD | Academic Supervisor |
Documents provided by Imperial College London:
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT05058989 |
Other Study ID Numbers: |
20HH5790 |
First Posted: | September 28, 2021 Key Record Dates |
Last Update Posted: | October 6, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
CVI VV |
Venous Insufficiency Varicose Veins Vascular Diseases Cardiovascular Diseases |