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The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy

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ClinicalTrials.gov Identifier: NCT05058989
Recruitment Status : Not yet recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief 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).

Condition or disease Intervention/treatment
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

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Group/Cohort Intervention/treatment
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.
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):

  • 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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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:

  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.



Information from the National Library of Medicine

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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
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mohammed Aslam, PhD +44 20 3313 1541 m.aslam@imperial.ac.uk
Contact: Reem Alturki, MSc +44 20 3313 1541 r.alturki18@imperial.ac.uk

Locations
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United Kingdom
Imperial College London
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Investigators
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Study Director: Mohammed Aslam, PhD Academic Supervisor
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Informed Consent Form  [PDF] May 16, 2021

Publications:
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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: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
CVI
VV
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Vascular Diseases
Cardiovascular Diseases