Clinical trial NCT05122195: Graduated Elastic compRession for vAricose Veins in PrEgnancy
Official title: Effect of Graduated Elastic compRession Hosiery on vAricose Veins and Leg Edema in PrEgnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Pregnancy Related
Quality of Life
Keywords: VV's
GSV
SSV
QoL
Lead sponsor: Belarusian State Medical University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women (between the 12th and 15th weeks of gestation) with primary varicose vein disease and C1-C3 are included in the prospective consecutive case study if they satisfied the selection criteria.

Brief summary: This study will be evaluate the clinical efficacy of using graduated compression hosiery for venospecific symptoms, leg edema, and quality of life (QoL) in pregnant women with varicose veins (VV's).

Detailed description: Each pregnant woman randomly receive an envelope. Those who received numbers 01 to 40 constitute the intervention group, and those with numbers 41 to 80 are in the control group.The intervention group will use a thigh length stockings with a compression of 23-32 mmHg, at least 8 hours a day. Verbal and written instructions on the proper use of the stockings will provide. During follow-up period, monitoring the regular use of compression stockings are performed every week. The physical characteristics of the patients, including the age, height, weight, and gestational week, are obtained and recorded. The clinical evaluation are performed using clinical-etiological and anatomical-pathophysiological assessment based on the CEAP classification.

Clinical examinations, QoL assessment and duplex-ultrasound will perform two qualified physicians in the 160 lower limbs of the 80 pregnant women with VV's at three landmark periods: between the 12th and 15th (initial examination), 20th and 28th (intermediate examination), and between the 28th and 36rd (final examination) week of gestation. The study protocol includes examination of the deep and superficial venous system with recording the reflux time and great and small saphenous veins (GSV/SSV) diameters in seven preestablished points, 5 points in the GSV and 2 points in the SSV. A reflux time in the superficial veins above 0.5 s is considered pathological reflux.

The ankle and lower leg circumference are measured using a measuring tape. Measurements are carried out at the lateral and medial ankle and the middle of the lower leg. All measurements are carried out at the same time of the respective days in the late afternoon or early evening; before the measurements the patients underwent a 45-min temperature and cardiovascular equilibrium period in a sitting position.

The QoL and subjective symptoms: tired, heavy legs, sensation of tension, tingling, and pain are assessed at each visit before the volume measurements and ultrasonographic evaluation. The subjective symptoms are evaluated by use of a semiquantitative scale from 0 to 3: 0 = no symptoms; 1 = mild; 2 = moderate; and 3 = severe. The QoL is investigated at each visit by a Chronic Venous Insufficiency Questionnaire (CIVIQ).

Eligibility criteria: Inclusion Criteria:

1. Pregnant women who are between the 12th and 15th weeks of gestation.
2. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C1-C3.
3. Ability to comprehend and sign an informed consent document.

Exclusion Criteria:

1. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
2. Postoperative varicose vein disease recurrence.
3. History of pulmonary embolism.
4. Current compression therapy (within 7 days of enrollment).
5. CEAP clinical class C4-C6.
6. Arterial occlusive disease and lymphatic pathology of lower limbs.
7. Edema of limbs other than of venous origin.

Primary outcomes:
measure: Responders to Treatment, Assessed by Duplex Ultrasound
timeFrame: 8 weeks
measure: Responders to Treatment, Assessed by Duplex Ultrasound
timeFrame: 16 weeks
measure: Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound
timeFrame: 8 weeks
measure: Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound
timeFrame: 16 weeks
measure: Responders to Treatment, Assessed by a measuring tape
timeFrame: 8 weeks
measure: Responders to Treatment, Assessed by a measuring tape
timeFrame: 16 weeks
measure: Number of Participants with pain from absent (score 0) to severe (score 3)
timeFrame: 8 weeks
measure: Number of Participants with pain from absent (score 0) to severe (score 3)
timeFrame: 16 weeks
measure: Number of Participants with heavy legs from absent (score 0) to severe (score 3)
timeFrame: 8 weeks
measure: Number of Participants with heavy legs from absent (score 0) to severe (score 3)
timeFrame: 16 weeks
measure: Number of Participants with tired legs from absent (score 0) to severe (score 3)
timeFrame: 8 weeks
measure: Number of Participants with tired legs from absent (score 0) to severe (score 3)
timeFrame: 16 weeks
measure: Number of Participants with sensation of tension from absent (score 0) to severe (score 3)
timeFrame: 8 weeks
measure: Number of Participants with sensation of tension from absent (score 0) to severe (score 3)
timeFrame: 16 weeks
measure: Number of Participants with tingling from absent (score 0) to severe (score 3)
timeFrame: 8 weeks
measure: Number of Participants with tingling from absent (score 0) to severe (score 3)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Vladimir Khryshchanovich
state: Minsk Region
city: Minsk
country: Belarus
facility: Belarusian State Medical University
Study officials:
affiliation: Educational Institution "Belarusian State Medical University"
name: Vladimir Khryshchanovich
role: STUDY_CHAIR
References:
citation: Allegra C, Antignani PL, Will K, Allaert F. Acceptance, compliance and effects of compression stockings on venous functional symptoms and quality of life of Italian pregnant women. Int Angiol. 2014 Aug;33(4):357-64.
citation: Gardenghi LA, Dezotti NRA, Dalio MB, Martins WP, Joviliano EE, Piccinato CE. Lower limb venous diameters and haemodynamics during pregnancy and postpartum period in healthy primigravidae. Phlebology. 2017 Dec;32(10):670-678. doi: 10.1177/0268355516671586. Epub 2016 Dec 6.
citation: Smyth RM, Aflaifel N, Bamigboye AA. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2015 Oct 19;2015(10):CD001066. doi: 10.1002/14651858.CD001066.pub3.
citation: Thaler E, Huch R, Huch A, Zimmermann R. Compression stockings prophylaxis of emergent varicose veins in pregnancy: a prospective randomised controlled study. Swiss Med Wkly. 2001 Dec 1;131(45-46):659-62. doi: 10.4414/smw.2001.09805.