Graduated Elastic compRession for vAricose Veins in PrEgnancy

• Conditions: Varicose Veins; Pregnancy Related; Quality of Life
• Interventions: Other: Compression therapy

• Registration Number: NCT05122195
• Lead Sponsor: Belarusian State Medical University

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).

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Primary Completion: 2021-11-15
• Study First Posted: 2021-11-16
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-24
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A, compression therapy group	Compression therapy	Elastic compression therapy with a thigh length stockings of 23-32 mmHg, at least 8 hours a day.

Primary Outcome Measures

Name	Time	Method
Number of Participants with pain from absent (score 0) to severe (score 3)	16 weeks	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound	16 weeks	Responders; Number of Participants with reduction of the GSV and SSV diameters between the 28th and 36th weeks of gestation
Responders to Treatment, Assessed by a measuring tape	16 weeks	Responders; Number of Participants with reduction of the ankle and lower leg circumference between the 28th and 36th weeks of gestation
Responders to Treatment, Assessed by Duplex Ultrasound	16 weeks	Responders; Number of Participants with eliminated superficial pathological reflux between the 28th and 36th weeks of gestation
Number of Participants with heavy legs from absent (score 0) to severe (score 3)	16 weeks	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Number of Participants with tired legs from absent (score 0) to severe (score 3)	16 weeks	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Number of Participants with sensation of tension from absent (score 0) to severe (score 3)	16 weeks	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Number of Participants with tingling from absent (score 0) to severe (score 3)	16 weeks	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)

Trial Locations

Locations (2)

Belarusian State Medical University; 🇧🇾 Minsk, Belarus

Vladimir Khryshchanovich; 🇧🇾 Minsk, Minsk Region, Belarus