The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
Condition: Varicose Veins; Varicose Veins of Lower Limb; Chronic Venous Insufficiency; Varicose; Vessel
MeSH terms: Venous Insufficiency; Varicose Veins
Study type: Observational

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).
    

Detailed description: 
      Initially, patients will be approached by a member of the direct care team in the Maternity
      outpatients' departments in the following hospitals: West Middlesex hospital, Queen
      Charlotte's and Chelsea hospital and St Mary's hospital. This will be managed by experienced
      research professionals in the area of vascular surgery. If a patient is prepared to discuss
      their potential role in this research, then the researchers will discuss the study and
      recruitment details at the patient's convenience. Recruitment is completely voluntary and
      will not affect their routine care, this will be made clear during the discussion regarding
      the research, and again during the consenting process. Time will be made available for any
      questions and for the patient to consider recruitment in their own time. Patients will be
      required to consent before any study-related procedures are carried out. Then her personal
      identifiable data will be coded and pseudonymised.

      The recruited patient will be interviewed to obtain clinical information that is essential
      for robust analysis. This clinical information will include standard demographic form which
      will be used for all patients in each follow up in order to record and gather important
      information which represents the composition of the target population. Gathered data will
      include patients' details; patients name, day of visit, hospital name, ID number, date of
      birth. Furthermore, this demographic form will record potential risk factors which may
      associate with VV development such as race, number of pregnancies, family history of venous
      disease, BMI which include weight and height, occupational factors, smoking, alcohol
      consumption and diet. Any complications arising from pregnancy will be also recorded.
      Finally, this proposed study will only record fetal weight in second and third trimester to
      correlate increased fetal weight with potential venous pathology.

      First, patients will be asked to fill the demographic form then will be asked to stand on a
      scale to measure the weight. Height will be recorded by bringing the horizontal measure down
      to rest on the top of the participants head. Following this, patient will be asked to sit
      while measurements are recorded in a relevant source data sheet.

      Next, the patient will be asked to stand on a step facing the sonographer to assess the
      incidence of varicose veins using Duplex ultrasound (DUS) and vector flow imaging (VFI).
      While patient is standing, Truncated cone tool will be performed immediately by measuring leg
      circumferences in each segments of each limb to produce accurate measurements of lower limbs
      volume. Following this, patient will be asked to sit on a chair for perform Iliac vein
      compression test (venous outflow function) using photoplethysmography (PPG) technique.
      Finally, patient's quality of life assessment will be evaluated by using Aberdeen Varicose
      Veins Questionnaire (AVVQ) check list. Thereafter, the patient will be thanked for their
      participation and excused.

      Clinical Laboratory tests will be managed and performed by experienced research professionals
      in the area of vascular surgery. Four appointments will be arranged for each patient to
      investigate DNA genomic testing and Estriol (E3) and progesterone hormonal testing. First
      appointment during first trimester will include both genomic DNA and hormonal blood tests.
      The three remaining appointments in the second trimester, third trimester and three months
      after giving birth will include hormonal blood samples only. Patients will be entitled to
      exit the study at any time without providing a reason, this is clearly stated on our
      information sheet and consent form. Verbal consent will be requested before all follow-up
      ultrasound scans.

      Researchers will ensure that demographic data, ultrasound data, lower limb volume and iliac
      vein compression measurements, histopathological results and quality of life assessment
      results will be collected and stored in such a way that confidentiality is preserved. All
      data will be pseudonyms by replacing names with research codes and by keeping any identifying
      information separate from the main dataset.

      The data will be analysed with the help of the Imperial College statistics department. The
      results of this study may be presented at local, national or international meetings or
      submitted for publication in a peer-reviewed journal. From a patient's perspective, all data
      will be pseudonyms before the statistical analysis phase of the study and plans to publish
      the results of the study are made clear in our patient information sheet.

      Data and all appropriate documentation will be stored for a minimum of 10 years after the
      completion of the study, including the follow-up period.
    

Intervention name(s): Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI); Clinical interventions and procedures
Intervention type(s): Diagnostic Test; Other
Intervention description(s): 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).; 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
Other intervention name(s): photoplethysmography (PPG) technique
Observational model: Cohort
Time perspective: Retrospective
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.
      
Biospecimen description: 
      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.
    
Keywords: CVI; VV