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National Clinical Guideline Centre (UK). Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins. London: National Institute for Health and Care Excellence (NICE); 2013 Jul. (NICE Clinical Guidelines, No. 168.)
It was identified during the scoping stage that as varicose veins are common during pregnancy (affecting about 40% of pregnant women) that this group required additional consideration in the guideline. The management of vulval varicose veins is out of the scope of this guideline.
11.1. Clinical evidence
None of the literature searches completed for the review questions within the guideline excluded pregnancy as a condition. Therefore we can be confident that all the clinical evidence concerning the management of varicose veins during pregnancy is likely to have been identified. This section aims to collate and summarise the findings across different guideline questions to allow recommendations to be made for this group.
The summary below summarises the literature on pregnant women that was included in the review questions. It also summarises the literature relevant to pregnant women that was not originally included in specific review questions because of exclusion criteria specific to those questions. Evidence tables are available in appendix G
11.1.1. Information and perceptions about varicose veins in relation to pregnancy
Chapter 5 reviews the evidence for the perceptions and expectations of people with varicose veins. Although it is unclear from the evidence how many of the participants were, or had been pregnant, Zubilewicz 2009110, in a survey of patient knowledge of CVI risk factors, found that 58% of patients identified prior pregnancy as a risk factor. This study was assessed to be of very low quality. The principles of giving accurate information to pregnant women are the same as those found in the recommendations in chapter 5, although the risks should be modified based on their condition.
11.1.2. Pregnancy as a risk factor for the progression of varicose veins
Chapter 6.1 investigated the evidence for risk factors which were associated with an increased chance of progression to more serious varicose veins. Two studies were identified which looked at pregnancy as a risk factor for progression.
Venous Reflux
Fowkes 200137 detected a univariate trend for previous pregnancies to be associated with the existence of venous reflux [OR: 1.20 (0.93-1.54)], but this effect disappeared after multivariable analysis [OR: 0.96(0.71-1.29)]. Note that this is not an outcome relevant to progression of varicose veins, as the study was cross-sectional, and there was no measure of any change in severity status. No analysis was undertaken to establish associations between pregnancy and varicosities.
The quality of this outcome was classified as low, downgraded for the lack of assessor blinding and the use of a cross-sectional analysis. This evidence has not been previously included in the guideline as we do not have a review question addressing etiological factors for the incidence of varicosities or reflux; however, this is an important issue in the context of pregnancy.
Progression of varicose veins
Mota Capitao 199563 assessed prior pregnancy as a possible risk factor for progression of varicose veins, but after multivariable analysis it was not shown to be a significant risk factor. The quality of this outcome was classified as very low, downgraded for indirectness, use of a cross-sectional methodology, and a lack of blinding of assessors.
11.1.3. Pregnancy as a predictor of treatment outcome
Chapter 6.2 investigated risk factors which predicted a better or worse outcome after interventional treatment. One study was identified which looked at pregnancy.
Fischer 200635 assessed previous pregnancy as one of many factors influencing reflux recurrence after great saphenous vein ligation and stripping. After multivariable analysis, prior parity was an independent predictor, leading to a 2.69 fold increase in the odds of reflux recurrence (95% CIs: 1.45- 4.97) compared to no parity. Interim pregnancy during follow-up was also an independent predictor of reflux [OR: 4.74(2.47-9.12)]. The quality of these outcomes were classified as moderate, with a single downgrade for the lack of assessor blinding.
11.1.4. Interventions for varicose veins in pregnancy
Chapters 8 and 9 investigate compression and interventional treatment options for the management of varicose veins. All of the studies included in these sections excluded pregnant women.
Thaler 2001104 evaluated compression stockings as prophylaxis of varicose veins in pregnancy (population of all pregnant women under 12 weeks gestation, with no baseline reflux) compared to no treatment. Compression failed to prevent the emergence of superficial varicose veins, although it did appear to reduce the risk of GSV reflux and worse symptoms in those that already had mild varicose veins at baseline. The quality of the three relevant outcomes from this study were all classified as low, based on a lack of allocation concealment and inadequate blinding. Our reason for excluding this study from the compression compared with no treatment review question (chapter 8) was that prophylaxis was out of the scope of the guideline.
11.1.5. Related NICE guidance
NICE produced a guideline on routine care for the healthy pregnant woman (NICE Antenatal guidelines) in 2008.66 Within this guideline there was one recommendation for women with varicose veins:
“Women should be informed that varicose veins are a common symptom of pregnancy that will not cause harm and that compression stockings can improve the symptoms but will not prevent varicose veins from emerging.”
This recommendation was based on was based on the findings from Thaler 2001104.
11.1.6. Economic evidence
Published literature
No cost effectiveness evidence was identified for this specific population.
11.1.7. Evidence Statements
11.1.7.1. Clinical
- One low quality study comprising 42 participants showed that compression does not prevent the incidence of varicose veins in pregnant women [LOW QUALITY].
- One low quality study comprising 42 participants showed that compression may decrease the risk of progression of varicose veins in pregnant women [LOW QUALITY].
- One low quality study comprising 42 participants showed that compression may decrease the symptoms from varicose veins in pregnant women [LOW QUALITY].
- One low quality study comprising 739 participants showed that pregnancy does not have an association with the existence of venous reflux [LOW QUALITY].
- One very low quality study comprising 474 participants showed that prior pregnancy does not influence progression of varicose veins [LOW QUALITY].
- One moderate quality study comprising 1261 participants showed that prior pregnancy may increase the risk of reflux recurrence after varicose veins surgery [LOW QUALITY].
- One moderate quality study comprising 1261 participants showed that interim pregnancy at follow-up may increase the risk of reflux recurrence after varicose veins surgery [LOW QUALITY].
11.1.7.2. Economic
- No cost effectiveness evidence was found for this specific population.
11.2. Recommendations and link to evidence
11.2.1. Provision of information
| Recommendations |
|
|---|---|
| Relative values of different outcomes | The outcomes used in this review were any reported in the papers reviewed for chapter 5. The GDG considered any reported perceptions and expectations as equally important. The possible adverse events both to the woman and her unborn child were considered by the GDG in their decision making. |
| Trade off between clinical benefits and harms | No evidence was identified evaluating the perceptions and expectations of pregnant women with varicose veins (chapter 5). The GDG considered that there are few, if any, harms from exploring perceptions and expectations at the initial consultation and by providing accurate information for people with varicose veins. The GDG considered that the clinical benefits of providing information to women with varicose veins during pregnancy did not outweigh the possible harms to the woman and the unborn child. |
| Economic considerations | It was expected that the impact of providing patient information on time and resource use would be minimal, and would likely be offset by an improvement in quality of life. |
| Quality of evidence | The quality of the study included in the review is considered to be very low. |
| Other considerations | On the whole advice given to pregnant women is no different anyone else with varicose veins except the GDG was aware of evidence that indicated that although varicose veins may appear during pregnancy, that there was a chance that these would regress in the postnatal period. This was also their experience clinically and the GDG felt that pregnant women should be made aware of this. |
11.2.2. Interventional treatment during pregnancy
| Recommendation |
|
|---|---|
| Research recommendation |
|
| Relative values of different outcomes | Health related quality of life was considered the most important outcome for this question. Patient reported relief from symptoms associated with chronic venous insufficiency was also considered an important outcome. This included pain, ankle swelling, cramps and the feeling of having tired / heavy legs. The possible adverse events both to the woman and her unborn child were considered by the GDG in their decision making. |
| Trade off between clinical benefits and harms | The GDG considered that the clinical benefits of interventional treatment for varicose veins during pregnancy did not outweigh the possible harms to the woman and the unborn child. The evidence for this review came from the review of the role of compression (chapter 8) and interventional treatments (chapter 9) in the management of varicose veins. None of the studies included pregnant women. |
| Economic considerations | The primary concern is safety for the woman and the unborn child; treatment is not advised in pregnant women, therefore cost-effectiveness is not considered. |
| Quality of evidence | None of the studies included in the intervention reviews included pregnant women. |
| Other considerations | The GDG commented that due to the lack of evidence and lack of safety information, interventional treatment of varicose veins should not normally be offered to women during pregnancy. However there may be some exceptional situations, for example when a woman has bleeding varicosities, where intervention could be considered. These situations should be referred to a vascular specialist for their assessment of the risks and benefits of interventional treatment. The GDG discussed the length of time after giving birth before varicose veins interventional treatments should be given. There was a general consensus that this should be at least 3-6 months due to normalisation of the body after giving birth and the risk of introducing drugs during breastfeeding. The GDG agreed that they wished to avoid being too specific because of the dearth of evidence. They have included as a future research recommendation to investigate when after pregnancy it was it safe to give interventional treatment for varicose veins. The GDG discussed whether women should have their varicose veins treated ‘between’ pregnancies or advised to wait until they do not plan to have any more children. They did know of any evidence of why a woman should have to wait until she did not think she would have any more children before having treatment and felt that it was an outdated concept. As there was no evidence the GDG suggested that some research could be completed into this area, although they noted that it was likely that this would be an observational study as a trial would not be a feasible or ethical to complete. |
11.2.3. Compression hosiery during pregnancy
| Recommendations |
|
|---|---|
| Relative values of different outcomes | Health related quality of life was considered the most important outcome for this question. Patient reported relief from symptoms associated with chronic venous insufficiency was also considered an important outcome. This included pain, ankle swelling, cramps and the feeling of having tired/heavy legs. The possible adverse events both to the woman and her unborn child were considered by the GDG in their decision making. |
| Trade-off between clinical benefits and harms | The GDG considered that the clinical benefits of treating varicose veins with compression hosiery during pregnancy may outweigh the possible harms to the woman and the unborn child. Although compression therapy may be less cost effective than interventional therapy, the fact that interventional therapies were contraindicated means that compression is the only viable option. |
| Economic considerations | The GDG believe that the improvements in quality of life from compression therapy are likely to justify the additional cost; therefore compression hosiery is considered to be cost-effective (compared to no treatment) for women during pregnancy. |
| Quality of evidence | No studies were found for this question which included pregnant women. The GDG noted that there was one study of compression stockings in pregnant women which was excluded from our review of compression vs. no treatment as not all of the women had varicose veins at the start of the study and as such it was a trial of prophylaxis. The NICE antenatal guideline has reviewed this paper in full. |
| Other considerations | The GDG noted that the Royal College of Obstetricians and Gynaecologists (RCOG) have not produced any guidelines for treating varicose veins during pregnancy. The GDG were aware of the current NICE antenatal guideline which included one recommendation for pregnant women with varicose veins. Although they agreed with the spirit of the recommendation (i.e. that pregnant women should be considered for compression hosiery) they did not agree with the precise wording and did not want to reference it in their recommendations. The GDG highlighted that the same issues as when considering compression in any other populations should be taken into account such as measuring the person’s legs and prescribing properly fitting hosiery, providing advice about wearing compression etc. These are discussed in the LETR for chapter 8. |
- Pregnancy - Varicose Veins in the LegsPregnancy - Varicose Veins in the Legs
- LINC02144 long intergenic non-protein coding RNA 2144 [Homo sapiens]LINC02144 long intergenic non-protein coding RNA 2144 [Homo sapiens]Gene ID:105379069Gene
- LINC02045 long intergenic non-protein coding RNA 2045 [Homo sapiens]LINC02045 long intergenic non-protein coding RNA 2045 [Homo sapiens]Gene ID:105374146Gene
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