Graduated Elastic compRession for vAricose Veins in PrEgnancy (GRAPE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Pregnancy Related; Varicose Veins
• Intervention / Treatment: Other: Compression therapy

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Vladimir Khryshchanovich; Phone Number: +375296245578; Email: vladimirkh77@mail.ru
• Study Contact Backup: Name: Nicolay Rogovoy, MD; Phone Number: +375293852753; Email: kolia_med@mail.ru

Study Locations

• Belarus
  • Minsk, Belarus, 220116
    • Recruiting
    • Belarusian State Medical University
    • Contact: Vladimir Khryshchanovich; Phone Number: 80296245578; Email: vladimirkh77@mail.ru
  • Minsk Region
    • Minsk, Minsk Region, Belarus, 220116
      • Recruiting
      • Vladimir Khryshchanovich
      • Contact: Vladimir Khryshchanovich; Phone Number: +375296245578; Email: vladimirkh77@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A, compression therapy group; Elastic compression therapy with a thigh length stockings of 23-32 mmHg, at least 8 hours a day.	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.
Group B, control group; No compression therapy prescribed in the follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Belarusian State Medical University
• Investigators: Study Chair: Vladimir Khryshchanovich, Educational Institution "Belarusian State Medical University"

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: QoL; GSV; VV's; SSV
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 20140465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To evaluate the clinical efficacy of using graduated compression hosiery for venospecific symptoms, leg edema, and quality of life in pregnant women with varicose veins (VV's).
• IPD Sharing Time Frame: 05.2022
• IPD Sharing Access Criteria: To evaluate the clinical efficacy of using graduated compression hosiery for venospecific symptoms, leg edema, and quality of life in pregnant women with varicose veins (VV's).
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No