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The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy

NCT05058989 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2023-10-06

No results posted yet for this study

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).

Conditions

  • Varicose Veins
  • Varicose Veins of Lower Limb
  • Chronic Venous Insufficiency
  • Varicose; Vessel

Interventions

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

Clinical interventions and procedures

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

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Mohammed Aslam, PhD · Academic Supervisor

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-10-01
Completion
2022-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05058989 on ClinicalTrials.gov