The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy (NCT05058989) | Clinical Trial Compass
CompletedNot Applicable
The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
United Kingdom70 participantsStarted 2021-06-01
Plain-language 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. 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).
Who can participate
Age range
18 Years – 47 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The patency of the vein, the blood flow direction (antegrade/retrograde) and the peak reflux velocity are evaluated by Duplex ultrasound parameters.
Timeframe: 1 year, in each follow up (first, second, third trimester and three months after giving birth)