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临床试验/NCT05122195
NCT05122195Unknown不适用

Effect of Graduated Elastic compRession Hosiery on vAricose Veins and Leg Edema in PrEgnant Women

Belarusian State Medical University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Number of Participants with pain from absent (score 0) to severe (score 3)

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number of Participants with pain from absent (score 0) to severe (score 3)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 16 weeks

None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)

次要结局

未报告次要终点

研究者

发起方
Belarusian State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vladimir Khryshchanovich

Professor

Belarusian State Medical University

研究点 (2)

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