An observational study in Varicose Veins, Pregnancy Related and Quality of Life, sponsored by Belarusian State Medical University. Status unknown at 2 sites in Belarus. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by Belarusian State Medical University · Observational
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).
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).
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
This study's planned enrollment of 80 is below the median of 159 across 62 observational studies indexed under Varicose Veins.
Browse Varicose Veins studies →Belarusian State Medical University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elastic compression therapy with a thigh length stockings of 23-32 mmHg, at least 8 hours a day.
Other: Compression therapy
No compression therapy prescribed in the follow-up period.
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.
Responders to Treatment, Assessed by Duplex Ultrasound
Responders; Number of Participants with eliminated superficial pathological reflux between the 20th and 28th weeks of gestation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 16 weeks
Plan to share: 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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).
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Belarusian State Medical University