Varicose VeinsGRAPENCT05122195
Graduated Elastic compRession for vAricose Veins in PrEgnancy
An observational study of Varicose Veins and Pregnancy Related, run by Belarusian State Medical University at 2 sites in Belarus.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Varicose Veins, Pregnancy Related, Quality of Life
- What is being tested?
- Compression therapy
- How many people
- 80 participants
- Where
- 2 sitesBelarus
- Study dates
- 1 Jun 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belarus2 sites, 2 recruiting
- Recruiting
Vladimir Khryshchanovich
Minsk, Minsk Oblast, 220116
Vladimir Khryshchanovich, +375296245578, vladimirkh77@mail.ru
- Recruiting
Belarusian State Medical University
Minsk, 220116
Vladimir Khryshchanovich, 80296245578, vladimirkh77@mail.ru
About this study
Official title: 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).
Read the 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).
- Conditions
- Varicose Veins, Pregnancy Related, Quality of Life
- Being tested
- Compression therapy
- Keywords
- VV's, GSV, SSV, QoL
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A, compression therapy group | Elastic compression therapy with a thigh length stockings of 23-32 mmHg, at least 8 hours a day. Receives: Other: Compression therapy | |
| Group B, control group | No compression therapy prescribed in the follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders to Treatment, Assessed by Duplex Ultrasound
Responders; Number of Participants with eliminated superficial pathological reflux between the 20th and 28th weeks of gestation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Jun 2021
- Primary completion15 Nov 2021
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Khryshchanovich, Belarusian State Medical University
- Investigators
- Vladimir Khryshchanovich, Study chair, Educational Institution "Belarusian State Medical University"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122195
- Sponsor's protocol ID
- 20140465
- Acronym
- GRAPE
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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.
PubMed 25056167Gardenghi 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.
PubMed 27928067Smyth 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.
PubMed 26477632Thaler 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.
PubMed 11835115
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Graduated Elastic compRession Hosiery on vAricose Veins and Leg Edema in PrEgnant Women
- ClinicalTrials.gov ID
- NCT05122195
- Acronym / sponsor ID
- GRAPE / 20140465
- Conditions
- Varicose Veins, Pregnancy Related, Quality of Life
- Keywords
- VV's, GSV, SSV, QoL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, compression therapy group | – | Other: Compression therapyElastic compression therapy with a thigh length stockings of 23-32 mmHg, at least 8 hours a day. |
| Group B, control group | – | –No compression therapy prescribed in the follow-up period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression therapyGraduated 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. | Other | Group A, compression therapy group |
Primary outcome
Responders to Treatment, Assessed by Duplex Ultrasound
Time frame: 8 weeks
Responders; Number of Participants with eliminated superficial pathological reflux between the 20th and 28th weeks of gestation
Responders to Treatment, Assessed by Duplex Ultrasound
Time frame: 16 weeks
Responders; Number of Participants with eliminated superficial pathological reflux between the 28th and 36th weeks of gestation
Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound
Time frame: 8 weeks
Responders; reduction of the GSV and SSV diameters between the 20th and 28th weeks of gestation
Number of Participants with reduction of the GSV and SSV diameters, Assessed by Duplex Ultrasound
Time frame: 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
Time frame: 8 weeks
Responders; Number of Participants with reduction of the ankle and lower leg circumference between the 20th and 28th weeks of gestation
Responders to Treatment, Assessed by a measuring tape
Time frame: 16 weeks
Responders; Number of Participants with reduction of the ankle and lower leg circumference between the 28th and 36th weeks of gestation
Number of Participants with pain from absent (score 0) to severe (score 3)
Time frame: 8 weeks
None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Number of Participants with pain from absent (score 0) to severe (score 3)
Time frame: 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 heavy legs from absent (score 0) to severe (score 3)
Time frame: 8 weeks
None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Number of Participants with heavy legs from absent (score 0) to severe (score 3)
Time frame: 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)
Time frame: 8 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)
Time frame: 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)
Time frame: 8 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)
Time frame: 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)
Time frame: 8 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)
Time frame: 16 weeks
None (0), Occasional (1), Daily, intefering with, but not preventing daily activities (2), Daily, limiting most daily activities (3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Results publication: PubMed 25056167Allegra 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.
- Results publication: PubMed 27928067Gardenghi 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.
- Results publication: PubMed 26477632Smyth 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.
- Results publication: PubMed 11835115Thaler 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Khryshchanovich study chair
Educational Institution "Belarusian State Medical University"
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Pregnancy Related, run by Belarusian State Medical University at 2 sites in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Khryshchanovich (+375296245578, vladimirkh77@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders to Treatment, Assessed by Duplex Ultrasound (time frame: 8 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.