Graduated Elastic compRession for vAricose Veins in PrEgnancy
NCT ID: NCT05122195
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2021-06-01
2022-05-01
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A, compression therapy group
Elastic compression therapy with a thigh length stockings of 23-32 mmHg, at least 8 hours a day.
Compression therapy
Graduated elastic compression promote venous flow which is impaired by hormonal changes in the venous system during the gestational period and minimize the blocking effect of the gravid uterus.
Group B, control group
No compression therapy prescribed in the follow-up period.
No interventions assigned to this group
Interventions
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Compression therapy
Graduated elastic compression promote venous flow which is impaired by hormonal changes in the venous system during the gestational period and minimize the blocking effect of the gravid uterus.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
40 Years
FEMALE
No
Sponsors
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Belarusian State Medical University
OTHER
Responsible Party
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Vladimir Khryshchanovich
Professor
Principal Investigators
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Vladimir Khryshchanovich
Role: STUDY_CHAIR
Educational Institution "Belarusian State Medical University"
Locations
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Vladimir Khryshchanovich
Minsk, Minsk Oblast, Belarus
Belarusian State Medical University
Minsk, , Belarus
Countries
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Central Contacts
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Facility Contacts
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Vladimir Khryshchanovich
Role: primary
Vladimir Khryshchanovich
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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20140465
Identifier Type: -
Identifier Source: org_study_id