Journal of Reproductive Medicine Gynaecology & Obstetrics Category: Medical Type: Review Article

Elastic Venous Compression Devices for Pregnant and Post-Partum Women: Effects on Chronic Venous Disease Signs and Symptoms and Compliance

Olivier Joassard1*, Anne-Laure Kerveillant1 and Frédéric Carrois1
1 Laboratoires Innothera, 22 Avenue Aristide Briand, 94110 Arcueil, France

*Corresponding Author(s):
Olivier Joassard
Laboratoires Innothera, 22 Avenue Aristide Briand, 94110 Arcueil, France
Email:olivier.joassard@innothera.com

Received Date: Jul 10, 2024
Accepted Date: Jul 18, 2024
Published Date: Jul 25, 2024

Abstract

Pregnant women are at risk to develop Chronic Venous Disease (CVD) signs and symptoms. Compression therapy is one of the most effective conservative treatments for alleviating symptoms of CVD, particularly in pregnant women. While experts recommend the use of Elastic Venous Compression Devices (EVCDs) for pregnant women presenting symptoms and/or signs of CVD, there is a discrepancy regarding the recommendations and the real-life dispensation. Considering a loss of chance for the patient if a compression device is not used, the compliance is crucial for alleviating CVD signs and symptoms. EVCDs could exert their beneficial effects through a decrease of the diameter of the common femoral vein and the great and small superficial veins, thereby allowing previously incompetent venous valves to coapt, resulting in restoration of the venous competence of damaged vessels. An increase in blood flow velocity and venous emptying and a reduction in vein reflux are thus induced allowing a reduction of the signs and subjective symptoms of pain, oedema, and leg heaviness related to pregnancy. 

The purpose of this review is to present the effects of EVCDs on the first signs and symptoms of CVD (C0s to C3 of the CEAP classification) during pregnancy. After giving epidemiological data, we will describe the knowledge of recommendations of the use of EVCD during ante and post-partum, and the benefit of using EVCDs to alleviate symptoms and signs of CVD. Finally, we will review the real-life dispensation, compliance, and reticence to use EVCD.

Keywords

Chronic venous disease; Compliance; Elastic venous compression devices; Pregnancy

Introduction

Several terminologies are used in the literature to describe elastic compression devices: compression hosiery/garment, graduated compression stockings, medical compression stockings. The term stockings can be too restrictive as several formats are available in the market (knee-length socks, thigh-length stockings or tights/pantyhose). Elastic Venous Compression Devices (EVCDs) were also proposed to integrate all these different formats. Globally, all these elastic compression devices work by exerting the greatest degree of compression at the ankle, with the level of compression gradually decreasing up the garment. Compression therapy is one of the most effective conservative treatments for alleviating symptoms of chronic venous disease, particularly in pregnant women. 

During pregnancy, women are at an increased risk of venous thrombo-embolism, including deep vein thrombosis or pulmonary embolism [1]. Prevention of venous thrombo-embolism is, therefore, key in reducing maternal mortality rates. The Clinical-Etiology-Anatomy-Pathophysiology, abbreviated as CEAP, classification is an internationally accepted standard allowing the description of patients with chronic venous disorders. The clinical (C) aspect is the most widely used component of CEAP classification [2] and is based on objective clinical signs of chronic venous disease, scored between C0 to C6, supplemented according to presentation (A) for asymptomatic or (S) for symptomatic limbs. This review will focus on C0 (no visible or palpable signs of venous disease), C1 (telangiectasias or reticular veins), C2 (varicose veins) and C3 (oedema). 

The aim of the review is to give an overview of i) epidemiology regarding the first signs of chronic venous disease (C0s to C3) during pregnancy, ii) the knowledge of recommendations of the use of EVCD during ante and post-partum, iii) the effects of compression therapy in pregnant women, and iv) real-life dispensation, compliance, and reticence to use EVCD.

Chronic Venous Disease Epidemiology During Pregnancy

  • Symptomatic patients (C0s) 

The gestational changes related to pregnancy result in the occurrence of various subjective symptoms like the feeling of tiredness and heaviness of the legs, bursting sensation, resulting in a discomfort or pain on the lower limbs. Interestingly, 82% of pregnant women describe feelings of discomfort [3]. Pregnant women may also suffer from tiredness and heaviness of the legs from 6% to 93%, depending on the study [4-8]. This variability can be explained by the different methods used to assess symptom intensity, and by the subjective nature of this assessment. Furthermore, more than 60% suffered from pain [4-9] and 40% from bursting sensation in the limbs [7]. Lower-limbs itch sensations have been observed in 19% of the pregnant women [5]. 

  • Telangiectasias, spider veins (C1) 

The term telangiectasias was used in 1807 by Von Graf to describe superficial vessels, just visible to the human eye. Nowadays, this term is used for small cutaneous vessels from 0.1 to 1.0 mm diameter [10]. Importantly, the prevalence of telangiectasias in pregnant women is between 31% [5] and can affect more than 50% [11]. Women who had been pregnant at least once were more likely to have minor telangiectasias, or spider veins [12]. This is mainly influenced by the modifications of hormones levels [10]. However, most disappear post-partum. 

  • Varicose veins (C2) 

Varicose veins, classified as C2 by the Classification CEAP [2], are defined as tortuous, dilated superficial veins >3 mm in diameter [13,14]. A study conducted on 352 pregnant women showed that 20.5% presented varicose veins [11]. The number of previous pregnancies was positively associated with the presence of varicose veins [15-18]. The appearance or worsening of varicose disease during pregnancy can be explained by different factors like i) a mechanical compression of the uterus on the iliac veins by the gravid uterus and inferior vena cava, especially in the last trimester of pregnancy which may explain the emergence of vulvar varicose veins; ii) hormonal modifications; iii) an increase in the uterine blood debit; iv) an increase in volemia; and v) structural alterations of the venous wall [11]. These changes will increase the pressure on the venous valves in the lower limbs and contribute to the development of venous distention and potentially to varicose veins. 

  • Oedema (C3) 

Venous oedema is defined by a perceptible increase in volume of fluid in skin and subcutaneous tissue, characteristically indented with pressure. Venous oedema usually occurs in the ankle region, but may extend to leg and foot [13]. The venous oedema increases during the time-course of the pregnancy [7]. Leg edema (swelling) can affect up to 80% of pregnant women [3-9,19,20]. The discrepancies observed between studies on the percentage of pregnant women suffering from leg edema can be partly due to methodological differences, including the measurement system used, variability of the subject regarding the time of pregnancy. Interestingly, a study conducted by Ponnapula [20] described the location of the edema in the lower limb. On 100 post-partum women for whom 87% experienced swelling, the authors showed that the edema was mainly present in the foot, and the ankle and to a lower extend on the leg for 84%, 80%, and 52%, respectively [20] (Table 1).

Epidemiology of the clinical signs and symptoms of pregnant women Table 1: Epidemiology of the clinical signs and symptoms of pregnant women.

Recommendations of EVCD Use in Pregnant Women

The European Society for Vascular Surgery recommends the use of EVCDs for pregnant women presenting with symptoms and/or signs of chronic venous disease [21]. Furthermore, the French National Authority for Health (Haute Autorité de Santé, HAS) endorses the use of EVCDs during pregnancy and up to six weeks after delivery, or even six months after Cesarean section [22]. Finally, the National Institute for Health and Care Excellence (NICE) advocates EVCDs for symptom relief of leg swelling associated with varicose veins during pregnancy [23]. These considerations are followed by the United Kingdom National Health Service (NHS) who is in favor of EVCDs for pregnant women, by recommending the prescription of two pairs of EVCDs so that one can be worn while the other is being washed and dried [24] and these EVCDs should be replaced every six months [25]. 

The statement of two pairs is mainly based on practice as depicted by the publications of Allaert [26,27]. In 2008, in a cross-sectional study conducted in daily practice of downtown French pharmacies, it has been shown that the prescriptions included one, two and three or more pairs of compression in 44.8%, 51.9% and 3.3%, respectively [26]. Interestingly, in 2013, in a prospective study on the French general population conducted on 332 pharmacies, the authors showed that the number of pairs of compression is mentioned on 94.3% of prescriptions and those foreseen the dispensation of one, two and three pairs of compression in 26.9%, 65.8%, and 7.3%, respectively. The mean of prescription of compression was 1.9 ± 0.8 pair [27]. These results are in line with the one from Joassard et al., showing that among pregnant women who were dispensed at least one EVCD during ante or post-partum, the majority (41.9 %) were dispensed with two pairs of EVCDs [28].

Effects Of EVCD On Chronic Venous Disease Signs And Symptoms In Pregnant Women

EVCDs are assigned to classes 1 to 4, depending on the compression exerted on the leg, in a supine position, at the B point in the area of the ankle. EVCDs must exhibit a continual decline in pressure from distal to proximal, with the greatest pressure in the ankle region (B point) and the lowest pressure in the thigh region (G point). The pressures exerted by the EVCD, expressed in millimeters of Mercury (mmHg) or in hectoPascals (hPa) (1 mmHg = 1,33322 hPa), are determined based on laboratory measurements, according to standards. Unfortunately, there is no single standard used worldwide, which may cause confusion. There are three main standards for EVCDs: RAL-GZ 387/1 in Germany, BS 7505 in United Kingdom, and AFNOR in France. According to the most commonly used throughout the World, RAL-GZ 387/1, the ankle interface pressure is 18-21 mmHg (24-28 hPa) for Class 1, 23-32 mmHg (31-43 hPa) for Class 2, 34-46 mmHg (45-61 hPa) for Class 3 and > 49 mmHg (> 65 hPa) for Class 4 [29]. 

EVCD is one of the most effective conservative treatments for alleviating symptoms of chronic venous disease, particularly in pregnant women. Fourteen publications, published between 1992 to 2022, and focusing on the effect of EVCDs on pregnant women’s venous disorders or pregnancy-related symptoms were selected for this review (Table 2). These articles included 10 to 98 pregnant women. The thigh-length stockings format was the most studied (nine articles) [3,4,30-36], compared to one publication with tights compression devices [9] and four articles including knee-length socks [8,37-39] (Table 2). Several levels of compression were analyzed from 13 mmHg to 25-32 mmHg at the ankle (Tables 2&3). 

Reference

Study Design

Population /

Indication

Intervention /

Device

Comparator(s)

Outcomes

Main Results

Compression tights

Adamczyk et al., [9]

Randomized,

prospective study

21 pregnant women in the clinical stages C0 (3), C1 (11), C2 (6) and C3 (1)

Compression tights (23-32 mmHg) (n = 13)

No EVCD (n = 8)

-   Venous function with Doppler and duplex sonography

-   Compliance

-   Leg volumes over the course of the pregnancy using water plethysmography

-   Quality of life using patient questionnaires

-   Subjective complaint-symptoms (pain, swelling) using patient questionnaires

- No systematic change in the venous filling times t0 or t1/2 during pregnancy.

- Compression was worn for at least 4h, a majority longer than 4h, some even up to 12h.

- Increase in leg volume in both groups that increased linearly with body weight over the course of pregnancy. Significantly smaller increase in lower leg volume in the patient group with compression stockings (p <0.05).

- At the start of the study, the quality of life and the subjective symptoms were rated worse in the group with compression stockings than in the group without compression stockings. During the course of pregnancy, an improvement occurred.

Compression stockings

Nilsson et al., [3]

Prospective, observational study

29 women after their 35th

gestational week.

Graduated elastic compression hosiery (25 mmHg at the ankle level, 12 mmHg at the mid-thigh) worn for 3 days (n=29)

Same group, pre-EVCD (n = 29)

- Subjective discomfort of the legs, recognized as aches and pajn and edema.

- The venous emptying

 The refilling rate

-  Reduction of discomfort and edema to 13% and 14%, respectively with EVCD (82% of the women experienced discomfort and 75% had troublesome edema without EVCD). 86% of pregnant women claimed improvement with EVCD.

-  The expelled volume increased significantly from 13.8 ± 0.6 mL to 14.9 ± 0.5 mL (p = 0.002) with EVCD.

The refilling rate significantly reduced from 3.6 + 0.2 mL/min x 100 mL to 3.3 ± 0.2 mL/min x 100 mL (p = 0.04) with EVCD.

Büchtemann et al., [4]

Prospective, observational study

15 pregnant women with no clinical or Doppler ultrasound evidence of chronic venous insufficiency, at their 20th gestational week.

Compression stockings (25-32 mmHg at the ankle) (n = 15) worn daily, from the 1st visit throughout the study period.

Same group, no stockings (n = 15)

Examination: 20th (visit 1) and 36th (visit 2) gestational week and post-partum (visit 3).

- Using strain-gauge plethysmography technique:
- Venous pump function
- Refilling time
- Comparison of venous function in the right and left leg
Using Duplex sonography technique:
- Blood flow velocity
- Blood flow volume
- Vessel diameter of the superficial femoral vein
Subjective symptoms of the legs using a rank ordered severity scale from 0 (nonexistent) to 5 (very strong symptoms):
- Feeling of tiredness, heaviness, tension, pain and swelling in the legs before and under the daily applied compession.

-  - Venous pump function: The mean expelled volume increased significantly (P<0.0001) by the use of compression at all 3 visits. The mean angle α, an expression of venous emptying, enlarged significantly when compression worn at all 3 visits.
- Refilling time: The mean complete refilling time (t0) and the 50% refilling time (t1/2) lengthened significantly when compression was applied at all 3 visits.
- Comparison of venous function in the right and left leg: No statistically significant difference detected between left and right legs.
- Blood flow velocity: Significant acceleration at the 1st visit (P<0.05) and on the post-partum visit (P<0.005) with compression. The increase was not significant at the 2nd visit under compression.
- Blood flow volume: Increased under compression (reached significant values [P=0.0059] on the post-partum visit).
- Vessel diameter: Slightly reduced at the 1st visit and at the 2nd visit. Significant reduction (P=0.047) under compression at the post-partum visit.
- Subjective symptoms: Compression decreased significantly the subjective symptoms

Jamieson et al., [30]

Prospective, observational study

17 women on their 1st or 2nd day following a vaginal delivery of a singleton pregnancy at term.

Thigh-length compression (18 mmHg compression) (n = 17)

Same group, pre-EVCD (n = 17)

Using an ultrasound scanner:
- Diameter of the Common Femoral Vein (CFV) on the left leg.
- Blood flow velocity in the CFV

- Diameter of the CFV: Decreased significantly (P = 0.03) after application of EVCD.
- Blood flow velocity in the CFV: significantly increased after application of EVCD (P = 0.0001)

Thaler et al., [31]

Prospective randomized controlled trial

42 pregnant women

- Compression class I (18-21 mmHg) stockings on the left leg and a class II (25-32 mmHg) stockings on the right (Group 1) (n = 12)

 

- Compression class I (18-21 mmHg) stockings on the right leg and a class II (25-32 mmHg) stockings on the left (Group 2) (n = 15)

- No-stockings control group (controls) (n = 15)

- Compliance
- Emergence of varicose veins of any kind (truncular and side-branch varices, spider naevi and reticular varices) during pregnancy.
- Long saphenous reflux, using a Doppler ultrasound
- Leg symptoms (pain, discomfort, cramps).

- Compliance: No significant difference between Group 1 and Group 2.
- Emergence of varicose veins: No significant difference between the three groups.
- Long saphenous vein reflux at the sapheno-femoral junction: Significant (p = 0.047) difference between control and compressed women (4/15 controls vs. 1/27 compressed women) at visit 3.
- Leg symptoms: improved significantly (P = 0.045) in treated women (7/27) vs. controls (0/15) at both visits 2 and 3.

Austrell et al., [32]

Prospective, randomized controlled trial

58 pregnant women (close to gestational week 20)

- Low pressure graduated compression stockings (13 mmHg at the ankle, reduced by 50% at the thigh) (n = 22) worn daily

 

- Medium pressure graduated compression stockings (25 mmHg at the ankle, reduced by 50% at the thigh) (n = 28) worn daily

- No graduated compression stockings (n = 8)

3 examinations were performed:

·  the 1st one, close to gestational week 20 (range 18-25);

·  the 2nd one, around week 33 (range 30-37);

·  the 3rd one (except for non-stocking group), post-partum examination (median week 18).

- Compliance in using the compression stockings.

- Venous function, investigated by:
* Foot volumetry (FV, mL), a dynamic plethysmographic method performed with the patient standing and exercising with 20 knee-bendings during 40 seconds.
* Expelled venous volume (EV, mL) during the exercise
* Refilling rate after exercise (QmL/min x 100 mL).

- Compliance was 82%. No difference between those with low and those with medium compression levels.

* Foot volumetry: Increased significantly in all 3 groups from the 1st to the 2nd examination. In both compression groups, significant reduction from the 2nd examination to the follow-up.
* EV: Significantly increased at the 1st examination (P < 0.05) with both compression stockings compared to no stockings. In the medium compression group, EV even significantly higher at the final examination than at the 1st one. No difference at the 2nd examination.
* Refilling rate did not reach reflux values in any of the groups.

Austrell et al., [33]

Observational study

27 pregnant women (1 in gestational week 28, 26 between the 32nd and 38th gestational week).

Graduated compression stockings with a pressure of 25 mmHg at the ankle level and 12 mmHg at mid-thigh (n = 27)

No stockings (n = 27)

- Maternal heart rate (MHR, beats/min), recorded using an electrocardiogramm system in supine and vertical positions.
- Fetal heart rate (FHR, beats/min), recorded using a cardiotocograph.
- Flow velocity in the uterine artery (Vmax, m/s), recorded in supine and vertical positions.

- MHR increased significantly when the position was changed from lying to standing without stockings. Increase did not reach statistical significance when using stockings. Compression yielded a slower MHR in the standing position compared with the non-compression group.
- FHR: Without compression stockings the change in position from supine to elevation resulted in a small but significant increase, but when stockings were worn there was no increase in FHR. FHR significantly lower when the mother was standing with compression stockings.
- Flow Velocity: No change between the lying and standing position, either with or without stockings.

Allegra et al., [34]

Observational study

98 pregnant women with a C0s to C3s venous disease

- Compression stockings (15-20 mmHg) worn daily (n=10)

 

- Compression stockings 15-20 mmHg worn at least 2 times per week (n=58)

- No compression stockings (n=30)

 

- Compliance

- Leg pain

- Quality of life

- 30.6% (n=30) refused to wear compression stockings. 69.4% accepted wearing compression stockings, among whom 10.6% were not compliant to a daily wear and 58.8% wore them every day.

- Compression significantly decreased leg pain and quality of life more significant for pregnant women who accepted wearing compression stockings every day compared to those who were not compliant to a daily wear and those who refused.

Hobel [35]

 

18 normal pregnant between 23 and 33 weeks of pregnancy

Compression stockings (18 mmHg at the ankle and 10 mmHg at midthigh) for 1 week during the day.

 

At each evaluation the subjects were studied under three conditions: sitting, after lying in the lateral recumbent position for 40 minutes, and then in the standing position after ambulation for 40 minutes.

- Mean Arterial Pressure (MAP)

- Compliance

- Significant stocking effect (p = 0.049) resulting in an increase in MAP in each of the positions compared with the study period before the stockings were worn

- The compliance for wearing the stockings for >12 hours each day was 73%.

Norgren [36]

Observational study

10 women in their 30th to 36th gestational week

Graduated elastic compression stockings

(25 mmHg at the ankle and 12 mmHg at mid-thigh) (n=10)

Same group, no compression (n=10)

In supine and standing positions:

- Maternal heart rate (MHR)

- Fetal heart rate (FHR)

- Femoral blood flow velocity

- MHR increase (observed from supine to vertical change) significantly reduced when graduated compression applied.

- No significant modification of FHR with graduated compression.

- Graduated compression increased significantly (P=0.03) the femoral blood flow velocity in the standing position only.

Knee-length socks

Saliba Júnior [8]

Prospective, randomized controlled

clinical trial

60 women 10-15 week pregnant, with CEAP classification 0, 1, 2, or 3

 

Knee-length compression socks (20–30 mmHg),

for ≈ 8 h daily (n=30)

Control group (n=30)

- Using Duplex-ultrasound in an orthostatic position at 2 periods: between the 10th and 13th and between the 30th and 33rd week of gestation: Diameter of the great saphenous vein (GSV) and small saphenous vein (SSV).

- The symptomatology (pain, edema, leg heaviness, redness) and CEAP classification according to subjective evaluation at the beginning and end of gestation.

- Reflux time in the deep venous system.

- The perceived difficulties and advantages of using compression stockings evaluated at the end of the study, using a questionnaire

- Significant decrease of the GSV and SSV diameters in the intervention group (p<0.0001); Significant increase of the GSV and SSV diameters (p<0.0001) in the control group.

- The signs and symptoms in the control vs. intervention group worse for control: pain (86.67% vs. 23.33%; p<0.0001), edema (70.00% vs. 33.33%; p=0.0045), and leg heaviness (93.33% vs. 13.33%; p<0.0001). Redness reported in 2 pregnant women in the control group at the end of the study. None for the intervention group.

- CEAP classification presented worsening in the control group (p<0.0001) (from CEAP 1/2 at the beginning of pregnancy to CEAP 3 with appearance of CEAP 4 and 6). Most pregnant women classified under CEAP 2/3 at the beginning and end of gestation for intervention group.

- At the end of the study, no pregnant women with reflux time > 0.5 s in the GSV and SSV in the intervention group while 53.33% in the control group with reflux time > 0.5 s.

- No difficulty in wearing their compression socks reported. No need to remove socks during the study period in 63.33%. No need for assistance to put on the socks in 80%.

Junior et al., [37]

Controlled randomized clinical trial

60 pregnant women 10-15 weeks of gestation

Knee length socks (20-30 mmHg), 8 h daily (n=30), between the 10th-13th (initial examination) and the 30th-33rd (final examination) week of gestation.

No compression (Control group) (n=30)

In the Great Saphenous Vein (GSV) and the Small Saphenous Vein (SSV), using duplex-ultrasonography:

- Reflux time and peak

- Reflux velocity

Calf and ankle diameter at the beginning and at the end of pregnancy

- Significant decrease time and peak of venous retrograde flow during gestation with graduated compression.

- Significant decrease in the peak reflux velocity with graduated compression.

- Significant smaller increase (p<0.05) in calf and ankle diameter with compression.

Banba et al., [38]

Before-and-after study

24 pregnant women at 36 weeks of gestation with clinically presented lower leg edema

Below-knee graduated elastic compression socks (18-27 mmHg) [27 mmHg on the ankle and 18 mmHg on the calf] (n=24) for 1 week at 37-38 weeks of gestation.

Same group, no stockings (n = 24)

Using portable ultrasonography at 36, 37, and 38 weeks of gestation:

- Grade of edema (from 0 to 3)

- Skin thickness of the lower leg.

- The average grade of pitting edema significantly decreased after using the socks (36 weeks, 1.77 ± 0.85; 37 weeks, 1.79 ± 0.77; 38 weeks, 1.04 ± 0.74, p < 0.0001).

- The skin thickness significantly decreased after the use of elastic socks (36 weeks, 7.47 ± 2.45 mm; 37 weeks, 7.93 ± 2.83 mm; 38 weeks, 7.15 ± 2.35 mm, p < 0.0001).

Saliba Júnior [39]

Prospective, randomized, controlled, blind, clinical trial

60 women 10-15 week pregnant, with CEAP classification 0, 1, 2, or 3

Knee-length compression socks (20-30 mmHg),

for ≈ 8 h daily (n=30)

Control group (n=30)

- Calf and ankle diameters, using a tape measure.

- Perceived difficulties and advantages related to wearing compression stockings, using a questionnaire.

- Significantly smaller increase (p < 0.05) in calf and ankle diameters of the intervention group compared to those in the control group.

- No difficulty in wearing their compression socks reported. No need to remove socks during the study period in 63.33%. No need for assistance to put on the socks in 80%.

Table 2: Summary of clinical trials evaluating efficacy of EVCDs on pregnant women.

 

Parameter

Level of compression

Effect of

compression

Reference

Oedema

13 mmHg/25 mmHg

20-30 mmHg

23-32 mmHg

25 mmHg

27 mmHg

[32]

[8] [39]

[9]

[3]

[38]

Skin thickness

27 mmHg

[38]

Quality of life

15-20 mmHg

23-32 mmHg

[34]

[9]

Subjective symptoms

15-20 mmHg

18-21 mmHg/25-32 mmHg

20-30 mmHg

23-32 mmHg

25 mmHg

25-32 mmHg

[34]

[31]

 

[8] [39]

[9]

[3]

[4]

Vein diameter

18 mmHg

20-30 mmHg

25-32 mmHg

[30]

[8]

[4]

Blood flow/Venous pump function

·         Blood flow velocity

18 mmHg

25 mmHg

25-32 mmHg

      

[30]

[36] / [33]

[4]

·         Blood flow volume

25-32 mmHg

[4]

·         Venous emptying, Expelled volume

13 mmHg/25 mmHg

25 mmHg

25-32 mmHg

[32]

[3]

[4]

·         Refilling rate

25 mmHg

[3]

·         Vein reflux

18-21 mmHg/25-32 mmHg

[31]

·         Reflux velocity

20-30 mmHg

[37]

·         Time and peak of venous retrograde flow

20-30 mmHg

[8,37]

Heart Rate

·         Maternal

25 mmHg

[33]/ [36] (decrease not significant)

·         Fetal

25 mmHg

↓      

[33][36]

Arterial pressure

18 mmHg

[35]

Table 3: Summary of the effects of EVCDs on signs, symptoms and hemodynamic parameters on pregnant women.

  • Efficacy on the leg symptoms 

Leg symptoms (pain, discomfort) improved significantly (p = 0.045) in pregnant women wearing EVCDs compared to no EVCDs [31]. Several publications confirm these findings [3,4,8,9,34,39]. 

  • Efficacy on blood flow/venous pump function 

When EVCDs were worn during ante and post-partum, venous pump function improved [3,4,32] and refilling time lengthened significantly [4]. Duplex sonography showed an increase in blood flow velocity [30] and flow volume in the superficial femoral vein with applied compression; the vessel diameter decreased [4,8,30,37]. 

  • Efficacy on Oedema 

Oedema was reduced with 13 mmHg EVCDs [32] to 20-32 mmHg EVCDs [3,8,9,32,38,39]. Interestingly, the skin thickness significantly decreased after the use of 27 mmHg elastic socks [38]. Furthermore, the venous emptying (expelled volume), corresponding to a measure of the ability of the muscle pump and venous system to reduce the venous volume, was significantly increased after a 3-day compression period. A reduction of the inflow rate was also observed. Altogether, these results should be interpreted as a diminishing reflux induced by compression (Figure 1). This fact might be the reason for the lesser degree of edema subjectively evaluated [3]. Interestingly, a study, confirming these results, also quantitatively assessed the venous muscle pump function through pregnancy weeks 16, 30, 38 and 3 months (week 53) following delivery.

Effects of compression on pregnant women Figure 1: Effects of compression on pregnant women.

  • Efficacy on varicose veins 

The mean venous reflux increased significantly (p < 0.01), and was restored to initial values post-partum. On the contrary, while the expelled calf volume remained stable throughout pregnancy, an increase was observed following delivery [40]. Twenty five percent of pregnant women suffering with varicose veins have venous reflux [41]. While compression significantly decreased the reflux of the emergent third trimester long saphenous vein at the sapheno-femoral junction [4/15 for controls vs. only 1/27 compressed women (p = 0.047)], compression to a maximum of 32 mmHg fails to prevent the emergence of superficial varicose veins [31]. However, the group was too small to substantiate or exclude a benefit. A larger study would be required to determine whether compression prevent truncular varicosis in the long term. Interestingly, even low compression levels (13 mmHg at the ankle) were found to improve the venous emptying, measured during exercise in the standing position [32]. 

  • Efficacy on heart rate 

During pregnancy, an increase in heart rate on standing was recorded for both mother and fetus [33]. Interestingly, 25 mmHg at the ankle EVCDs decreased significantly these changes in the standing position, showing that 25 mmHg EVCDs are effective in the management of maternal and fetal circulatory response to alterations in posture during pregnancy [33]. However, these results were not confirmed later by Norgren et al., [36] that did not show significant decrease of mother and fetal heart rate [36]. Both studies were performed on small population, 18 and 10 pregnant women for Austrell et al., and Norgren et al., [33,36] respectively. Studies on larger pregnant population are needed to substantiate the effect of compression on both mother and fetal rates. 

EVCDs could exert their beneficial effects through a decrease of the diameter of the common femoral vein [30] and the great and small superficial veins [4,8], thereby allowing previously incompetent venous valves to coapt, resulting in restoration of the venous competence of damaged vessels. One could easily envisage a relation between a lower diameter of the veins and an increase in both blood flow velocity [4,30,36] and venous emptying [3,4,32]. Altogether, these results allow to reduce the signs and subjective symptoms of pain, oedema, and leg heaviness related to pregnancy [4,8,9,31,34] (Figure 1).

Real-Life Dispensation, Compliance, and Reticence to Use EVCD during Pregnancy

  • Real-life dispensation 

Recently, a retrospective cohort study (using the French Health Insurance database) conducted on 15,528 pregnant women showed that, in current practice, EVCD dispensation rates were low regarding the recommendations [28] made by the French National Authority for Health who is in favor of the EVCDs use during pregnancy and up to 6 weeks after delivery, or even 6 months after C-section [22]. In fact, authors noticed that only 31.7 % women were dispensed at least one EVCD during their pregnancy. During the post-partum period, 17.3 %, 46.7 % and 44.1 % women were dispensed at least one EVCD after vaginal delivery, planned C-section or unplanned C-section, respectively [28]. These interesting results on dispensation were either due to, on the one hand, a low level of prescription by healthcare professional or on the other hand, the fact that pregnant women did not provide their prescription for compression to the pharmacist. Importantly, the results of this retrospective study suggest that recommendations are not being followed by prescribers, or that there are issues with patient compliance. 

  • Compliance and reasons to not use EVCD 

Allegra et al., [34] showed that 30.6% of pregnant women presenting symptoms of venous disease (CEAP C0s to C3s) refused to wear compression stockings (15-20 mmHg) [34]. Among the pregnant women who accepted to wear compression stockings, 10.6% wear their compression at least once every two days and 58.8% wore them every day. Importantly, legs pain decreased more significantly for women wearing compression every day compared to women wearing compression at least once every two days and to women who did not wear compression. Similar results were observed for pregnant women quality of life. It was noticeable that the effect of EVCDs was proportional to the regularity of the pregnant women to wear the compression, confirming the efficiency of the EVCD in alleviating chronic Veinous Disease symptoms during pregnancy [34]. 

In the general population, while hot environments worsen venous disease symptoms [42,43], by increasing the leg volume [44] and the venous pressure in the great saphenous vein near the ankle [45], lower dispensation rates were observed in summer [28]. Also, a study conducted on 332 French pharmacists followed by 2,223 patients showed that the main reasons for the lack of regular wearing of EVCD were the difficulty to bear (in 23.8% of the cases), the difficulty of putting (in 14.5% of the cases), and the existence of a sufficient number of pairs in their disposition (in 24.5% of the cases) [27,46]. The lack of information given by healthcare professional regarding the interest and the real benefit of the EVCD, the way to don them, the storage and maintenance is also a reason of non-compliance by the patient [27,47,48]. Finally, an inappropriate dispensation of the adequate format (socks, stockings, or tights) underlined by Joassard et al., [28], and the poor choice in texture and color [46] may also contribute to the absence of compliance by the patient. Recently, a systematic review described five main overarching themes for non-compliance, including physical limitations, health literacy, discomfort, financial issues and psychosocial issues [49]. One could easily envisage that these reasons are also applicable to pregnant women. 

Interestingly, using a self-subjective evaluation questionnaire, the pregnant women’s perception on the use of 20-30 mmHg compression stockings, authors showed that most women stated that they did not have difficulty in wearing their compression stockings, did not need to remove them during the study period (63.33%), and did not need assistance to put on the stockings (80%). All pregnant women (n = 30) reported that they would use the compression stockings again as they felt an improvement of symptoms in their legs [8,39]. Furthermore, in a randomized trial, Coughlin et al., [41] investigated the acceptability, compliance and usage of Class 1 compression tights in 331 pregnant women at various time points (initiation, 34 weeks, and 6 weeks post-partum) via participant questionnaires. Authors notices a reticence at the beginning of the study to use compression. Furthermore, as pregnancy processed, the number of women rejecting the tights increased: seven women wore them up to 20 weeks, four to 28 weeks, 14 to 34 weeks, two to term and four to 6 weeks post-partum. Only 55% of the pregnant women stated that the tights were still comfortable at 34 weeks [41]. This is even more damaging as the venous symptoms worsen over time [8], season [42,43,50], and number of pregnancies [51]. Irritation was a reason why some participants stopped wearing tights. Coughlin et al., [41] concluded that Class 1 compression tights were unacceptable in pregnant women because of their abdominal size, being the most significant factor associated with tights rejection, suggesting the consideration of a different type of hosiery for pregnant women [41]. 

To be effective on the reduction of chronic venous disease symptoms and signs, EVCDs must be worn every day. It is therefore crucial that the pregnant woman is involved in the decision-making process, which may increase the likelihood that the EVCD will be worn. Progresses have been made regarding textile compression devices, in terms of technicity, formats (knee-length socks, thigh-length stockings or tights/pantyhose), open or closed toe, colors and aesthetics. In fact, some devices of elastic compression are dedicated to pregnant women like the one developed by Laboratoires Innothera: SMARTLEG® BB, co-designed by pregnant women and industrial engineers. These tights feature no seam under the belly, herringbone-designed sole. Furthermore, considered the physical dexterity conditions of pregnant women, particularly during late pregnancy, and as the maternity tights can be perceived as too tight in the abdominal and genital area [9], the belt of SMARTLEG® BB tights can be worn under the belly thanks to the V-design in the hip for a better compliance, especially in hot conditions and during ultrasonography screening.

Conclusion

In conclusion, during pregnancy, women are at an increased risk to see their quality of life being impaired due to modifications chronic venous disease signs and symptoms. EVCD has been considered to be one of the most effective conservative treatments for alleviating symptoms of chronic venous disease. EVCD works by exerting the greatest degree of compression at the ankle, with the level of compression gradually decreasing up the garment. The pressure gradient ensures that blood flows upward toward the heart instead of refluxing downward, especially by reducing the diameter of major veins. As signs and symptoms worsen with advanced pregnancy, the blood in the veins can become concentrated and may easily form blood clots, increasing the risk of venous thrombo-embolism, higher in post-partum. Importantly, even if several formats and compression class exist, it seems that the efficacy were not different on the signs, symptoms and hemodynamic parameters on pregnant women. However, there is a loss of chance for the patient if a compression device is not used; the compliance being crucial for alleviating chronic venous disease signs and symptoms. The most important consideration being that the EVCDs must be worn the earliest, every day during pregnancy and even in post-partum to prevent these blood conditions and impairment of pregnant women quality of life.

Conflict of Interests

This review was funded by Laboratoires Innothera.

Acknowledgment

The authors would like to thank Guillaume Duport for providing assistance in the design of the figure.

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Citation: Joassard O, Kerveillant A-L, Carrois F (2024) Elastic Venous Compression Devices for Pregnant and Post-Partum Women: Effects on Chronic Venous Disease Signs and Symptoms and Compliance. J Reprod Med Gynecol Obstet 9: 170.

Copyright: © 2024  Olivier Joassard, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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