Graduated Elastic compRession for vAricose Veins in PrEgnancy

NCT05122195 | Unknown

• 1 other identifier: 20140465
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Varicose Veins; Pregnancy Related; Quality of Life

Keywords

VV's; GSV; SSV; QoL

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

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

Group B, control group

No compression therapy prescribed in the follow-up period.

Interventions

Compression therapy OTHER

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 A, compression therapy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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-C3.
• Ability to comprehend and sign an informed consent document.

You may not qualify if:

• 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-C6.
• Arterial occlusive disease and lymphatic pathology of lower limbs.
• Edema of limbs other than of venous origin.

Sponsors & Collaborators

• Belarusian State Medical University: lead

Study Sites (2)

Vladimir Khryshchanovich

Minsk, Minsk Oblast, 220116, Belarus

RECRUITING

Belarusian State Medical University

Minsk, 220116, Belarus

RECRUITING

Related 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.

  PMID: 25056167 RESULT

• 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.

  PMID: 27928067 RESULT

• 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.

  PMID: 26477632 RESULT

• 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.

  PMID: 11835115 RESULT

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vladimir Khryshchanovich

  Educational Institution "Belarusian State Medical University"

  STUDY CHAIR

Central Study Contacts

Vladimir Khryshchanovich

CONTACT

+375296245578; vladimirkh77@mail.ru

Nicolay Rogovoy, MD

CONTACT

+375293852753; kolia_med@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 16, 2021
• Study Start: June 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: May 1, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 05.2022
• 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).

Locations

BE (2)