Graduated Elastic compRession for vAricose Veins in PrEgnancy

Quality of Life Clinical Trial

— GRAPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122195
• Other study ID #: 20140465
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2021
• Source: Belarusian State Medical University
• Contact: Vladimir Khryshchanovich
• Phone: +375296245578
• Email: vladimirkh77[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related
• Quality of Life
• Varicose Veins

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belarus	Belarusian State Medical University	Minsk
Belarus	Vladimir Khryshchanovich	Minsk	Minsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

References & Publications (4)

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. — View 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. — View Citation

Smyth RM, Aflaifel N, Bamigboye AA. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2015 Oct 19;(10):CD001066. doi: 10.1002/14651858.CD001066.pub3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responders to Treatment, Assessed by Duplex Ultrasound	Responders; Number of Participants with eliminated superficial pathological reflux between the 20th and 28th weeks of gestation	8 weeks
Primary	Responders to Treatment, Assessed by Duplex Ultrasound	Responders; Number of Participants with eliminated superficial pathological reflux between the 28th and 36th weeks of gestation	16 weeks
Primary	Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound	Responders; reduction of the GSV and SSV diameters between the 20th and 28th weeks of gestation	8 weeks
Primary	Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound	Responders; Number of Participants with reduction of the GSV and SSV diameters between the 28th and 36th weeks of gestation	16 weeks
Primary	Responders to Treatment, Assessed by a measuring tape	Responders; Number of Participants with reduction of the ankle and lower leg circumference between the 20th and 28th weeks of gestation	8 weeks
Primary	Responders to Treatment, Assessed by a measuring tape	Responders; Number of Participants with reduction of the ankle and lower leg circumference between the 28th and 36th weeks of gestation	16 weeks
Primary	Number of Participants with pain from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	8 weeks
Primary	Number of Participants with pain from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	16 weeks
Primary	Number of Participants with heavy legs from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	8 weeks
Primary	Number of Participants with heavy legs from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	16 weeks
Primary	Number of Participants with tired legs from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	8 weeks
Primary	Number of Participants with tired legs from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	16 weeks
Primary	Number of Participants with sensation of tension from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	8 weeks
Primary	Number of Participants with sensation of tension from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	16 weeks
Primary	Number of Participants with tingling from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	8 weeks
Primary	Number of Participants with tingling from absent (score 0) to severe (score 3)	None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)	16 weeks