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Aspirin and/or heparin for women with unexplained recurrent miscarriage with or without inherited thrombophilia

Recurrent miscarriage is associated with inherited blood clotting disorders that could interfere with the placental blood circulation. Recurrent miscarriage can also be unexplained, with no known cause. Anticoagulant drugs such as aspirin or low molecular weight heparin may help women with recurrent miscarriage and such an underlying blood clotting problem. These drugs may also cause bleeding (including nose bleeds and haematomas) in the mother, though not in the baby. Data from nine included randomised controlled trials (involving 1228 women) analysed in this review, provided no evidence to support the use of anticoagulants in women with recurrent miscarriage, regardless of the presence of inherited blood clotting disorders (thrombophilia).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Screening for thrombophilia in high-risk situations: systematic review and cost-effectiveness analysis. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) study

Thrombophilia is a recognised risk factor for venous thromboembolism (VTE). However, the optimal management is unclear in terms of the need for and effectiveness of antithrombotic interventions, especially in high-risk patient groups, including the use of oral oestrogen preparations, pregnancy and major orthopaedic surgery. Clinicians have come under pressure to initiate thrombophilia testing on an increasing number of patients and thrombophilia screening in selected patient groups has been suggested.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2006

Venous Thromboembolic Diseases: The Management of Venous Thromboembolic Diseases and the Role of Thrombophilia Testing [Internet]

Venous thromboembolism (VTE) is a condition in which a blood clot (a thrombus) forms in a vein and then dislodges to travel in the blood (an embolus). A venous thrombus most commonly occurs in the deep veins of the legs or pelvis; this is then called a deep vein thrombosis (DVT). Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg. If it dislodges and travels to the lungs, to the pulmonary arteries, it is called a pulmonary embolism (PE), which in some cases may be fatal. VTE as a term includes both DVT and PE. Major risk factors for VTE include a prior history of DVT, age over 60 years, surgery, obesity, prolonged travel, acute medical illness, cancer, immobility, thrombophilia (an abnormal tendency for the blood to clot) and pregnancy.

NICE Clinical Guidelines - National Clinical Guideline Centre (UK).

Version: June 2012
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Thrombophilia testing in people with venous thrombo-embolism: systematic review and cost-effectiveness analysis

Thrombophilias are heritable [such as factor V Leiden and the prothrombin G20210A mutation (PTG20210A)] or acquired (such as lupus anticoagulant) defects in blood coagulation that lead to a predisposition towards thrombosis. A thrombus is a solid mass of blood constituents that can fragment and block vessels downstream (thromboembolism). Depending on the blood vessel occluded, venous thromboemboli can lead to pulmonary embolism (PE) or, rarely, stroke.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2009

Heparin for pregnant women with acquired or inherited thrombophilias

No evidence from trials on the effects of heparin on pregnancy outcomes for women with a thrombophilia.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy

This clinical guideline concerns the management of hypertensive disorders in pregnancy and their complications from preconception to the postnatal period. For the purpose of this guideline, ‘pregnancy’ includes the antenatal, intrapartum and postpartum (6 weeks after birth) periods. The guideline has been developed with the aim of providing guidance in the following areas: information and advice for women who have chronic hypertension and are pregnant or planning to become pregnant; information and advice for women who are pregnant and at increased risk of developing hypertensive disorders of pregnancy; management of pregnancy with chronic hypertension; management of pregnancy in women with gestational hypertension; management of pregnancy for women with pre-eclampsia before admission to critical care level 2 setting; management of pre-eclampsia and its complications in a critical care setting; information, advice and support for women and healthcare professionals after discharge to primary care following a pregnancy complicated by hypertension; care of the fetus during pregnancy complicated by a hypertensive disorder.

NICE Clinical Guidelines - National Collaborating Centre for Women's and Children's Health (UK).

Version: August 2010
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Antenatal Care: Routine Care for the Healthy Pregnant Woman

The original antenatal care guideline was published by NICE in 2003. Since then a number of important pieces of evidence have become available, particularly concerning gestational diabetes, haemoglobinopathy and ultrasound, so that the update was initiated. This update has also provided an opportunity to look at a number of aspects of antenatal care: the development of a method to assess women for whom additional care is necessary (the ‘antenatal assessment tool’), information giving to women, lifestyle (vitamin D supplementation, alcohol consumption), screening for the baby (use of ultrasound for gestational age assessment and screening for fetal abnormalities, methods for determining normal fetal growth, placenta praevia), and screening for the mother (haemoglobinopathy screening, gestational diabetes, pre-eclampsia and preterm labour, chlamydia).

NICE Clinical Guidelines - National Collaborating Centre for Women's and Children's Health (UK).

Version: March 2008
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Screening for thrombophilia in high-risk situations: systematic review and cost-effectiveness analysis. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) study

OBJECTIVES: To assess the risk of clinical complications associated with thrombophilia in three high-risk patient groups: women using oral oestrogen preparations, women during pregnancy and patients undergoing major orthopaedic surgery. To assess the effectiveness of prophylactic treatments in preventing venous thromboembolism (VTE) and adverse pregnancy outcomes in women with thrombophilia during pregnancy and VTE in patients with thrombophilia, undergoing major orthopaedic surgery. To evaluate the relative cost-effectiveness of universal and selective VTE history-based screening for thrombophilia compared with no screening in the three high-risk patient groups.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2006

Preventing deep vein clots in pregnancy and after the birth

Venous thromboembolism (VTE) occurs when a blood clot forms in a deep vein, usually in a leg, forming a deep venous thrombosis (DVT), which may cause pain and swelling. This is very rarely fatal, but if part of the clot breaks off it may be carried to the lungs by the blood and block vessels there (this is called a pulmonary embolism (PE)), which can result in death. Normally occurring changes to the clotting system during pregnancy can increase the risk of a thromboembolic event (DVT or PE), and some groups of women have a higher risk of developing VTE (including older and obese women; women with previous VTE; women with thrombophilia (a condition predisposing individuals to developing clots); and women following a caesarean birth). Preventive treatments include drugs to prevent clots, support stockings, and physical activity soon after birth to keep the circulation moving. However, some drugs might cause problems such as increased blood loss after birth. Drugs used include unfractionated heparin, low molecular weight heparin and aspirin.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Venous Thromboembolism: Reducing the Risk of Venous Thromboembolism (Deep Vein Thrombosis and Pulmonary Embolism) in Patients Admitted to Hospital

Venous thromboembolism (VTE) is a term used to include the formation of a blood clot (a thrombus) in a vein which may dislodge from its site of origin to travel in the blood, a phenomenon called embolism. A thrombus most commonly occurs in the deep veins of the legs; this is called deep vein thrombosis. A dislodged thrombus that travels to the lungs is known as a pulmonary embolism.

NICE Clinical Guidelines - National Clinical Guideline Centre – Acute and Chronic Conditions (UK).

Version: 2010
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Thrombophilia testing in people with venous thromboembolism: systematic review and cost-effectiveness analysis

This review concluded that there were no eligible studies for the assessment of thrombophilia testing compared with no testing following a venous thrombotic event. Despite some concern over language bias and review methods at the selection stage, this conclusion reflects the results of an extensive search and is likely to be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Does low-molecular-weight heparin improve live birth rates in pregnant women with thrombophilic disorders? A systematic review

INTRODUCTION: Pregnancies in women with thrombophilia are associated with a higher risk of obstetric complications. We systematically reviewed the findings of relevant randomised controlled trials (RCTs) with the aim of investigating the effectiveness of low-molecular-weight heparins (LMWHs) in pregnant women with inherited thrombophilic disorders and its effect on the incidence of live births in these patients.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Adjunct low-molecular-weight heparin to improve live birth rate after recurrent implantation failure: a systematic review and meta-analysis

BACKGROUND Poor fertility outcomes in women with recurrent implantation failure (≥ RIF) present significant challenges in assisted reproduction, and various adjuncts, including heparin, are used for potential improvement in pregnancy rates. We performed this systematic review and meta-analysis to evaluate the effect of low-molecular-weight heparin (LMWH) on live birth rates (LBRs) and implantation rates (IRs) in women with RIF and undergoing IVF. METHODS Studies comparing LMWH versus control/placebo in women with RIF were searched for on MEDLINE, EMBASE, Cochrane Library, conference proceedings and databases for registered and ongoing trials (1980-2012). Statistical analysis was performed using Review Manager 5.1. The main outcome measure was LBR per woman. RESULTS Two randomized controlled trials (RCTs) and one quasi-randomized trial met the inclusion criteria. One study included women with at least one thrombophilia ( Qublan et al., 2008) and two studies included women with unexplained RIF ( Urman et al., 2009; Berker et al., 2011). Pooled risk ratios in women with ≥ 3 RIF (N = 245) showed a significant improvement in the LBR (risk ratio (RR) = 1.79, 95% confidence interval (CI) = 1.10-2.90, P = 0.02) and a reduction in the miscarriage rate (RR = 0.22, 95% CI = 0.06-0.78, P = 0.02) with LMWH compared with controls. The IR for ≥ 3 RIF (N = 674) showed a non-significant trend toward improvement (RR = 1.73, 95% CI 0.98-3.03, P = 0.06) with LMWH. However, the beneficial effect of LMWH was not significant when only studies with unexplained RIF were pooled. The summary analysis for the numbers needed to be treated with LMWH showed that approximately eight women would require treatment to achieve one extra live birth. CONCLUSIONS In women with ≥3 RIF, the use of adjunct LMWH significantly improves LBR by 79% compared with the control group; however, this is to be considered with caution, since the overall number of participants in the studies was small. Further evidence from adequately powered multi-centered RCTs is required prior to recommending LMWH for routine clinical use. This review highlights the need for future basic science and clinical research in this important field.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Guidance on the Use of Factor V Leiden and Prothrombin Mutation Testing in Patients With a First Unprovoked Thromboembolic Episode [Internet]

To assist decision-makers considering implementation or reassessment of factor V Leiden (FVL) and prothrombin gene (PG) mutation testing practices, CADTH’s Health Technology Expert Review Panel (HTERP) developed evidence-informed guidance on the optimal use of these tests for patients with unprovoked venous thromboembolism (VTE). The clinical and economic evidence used for developing guidance was derived from the following CADTH report:

CADTH Optimal Use Report - Canadian Agency for Drugs and Technologies in Health.

Version: March 2015
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Outcomes of Genetic Testing in Adults with a History of Venous Thromboembolism

To address whether Factor V Leiden (FVL) testing alone, or in combination with prothrombin G20210A testing, leads to improved clinical outcomes in adults with a personal history of venous thromboembolism (VTE) or to improved clinical outcomes in adult family members of mutation-positive individuals.

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US).

Version: June 2009
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Effectiveness of Factor V Leiden and Prothrombin Mutation Testing in Patients Presenting With a First Unprovoked Venous Thromboembolic Episode: A Systematic Review and Economic Analysis [Internet]

The objective of this report was to systematically review the available evidence on the association of a positive factor V Leiden (FVL) or prothrombin gene (PG) test with a first, unprovoked venous thromboembolism (VTE) (suspected thrombophilia), and the risks and benefits resulting from test use. The report focused on patients presenting with a first episode of unprovoked VTE. The cost implications of FVL and PG testing in Canada were also assessed. The following research questions were addressed:

CADTH Optimal Use Report - Canadian Agency for Drugs and Technologies in Health.

Version: March 2015
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Routine echocardiography in the management of stroke and transient ischaemic attack: a systematic review and economic evaluation

Study found that, transthoracic echocardiography in second harmonic imaging mode is a cost-effective use of NHS resources in those cases where clinicians deem it the most appropriate method of testing to identify cardiac sources of stroke and transient ischaemic attack. However, the study highlights that there is a lack of evidence in several areas and the results of the economic evaluation should be treated with caution.

Health Technology Assessment - NIHR Journals Library.

Version: March 2014
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The prognostic utility of tests of platelet function for the detection of ‘aspirin resistance’ in patients with established cardiovascular or cerebrovascular disease: a systematic review and economic evaluation

People with heart disease are often prescribed aspirin. Testing the function of platelets in the blood may be able to assess if aspirin is working properly. This review assessed all the evidence on the results of platelet function testing linked to the risk of having another cardiovascular event (such as a heart attack or stroke). The review found that people classified as ‘aspirin resistant’ by platelet function testing were, on average, slightly more at risk of having another cardiovascular event. However, the increase in risk was very small and it was not certain which was the most accurate of the platelet function tests available. Therefore, at the moment, the result of platelet function testing on its own is not very informative in determining a person’s future risk of cardiovascular events.

Health Technology Assessment - NIHR Journals Library.

Version: May 2015
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Low molecular weight heparin to achieve live birth following unexplained pregnancy loss: a systematic review.

This review concluded that although there was a trend for increased live births when low molecular weight heparin was used for the prevention of recurrent pregnancy loss, there was insufficient evidence to support its routine use. Given the level of heterogeneity and consequent lack of statistical synthesis, the reliability of this conclusion is unclear. The recommendations for research were appropriate.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Effectiveness of Assisted Reproductive Technology

We reviewed the evidence regarding the outcomes of interventions used in ovulation induction, superovulation, and in vitro fertilization (IVF) for the treatment of infertility. Short-term outcomes included pregnancy, live birth, multiple gestation, and complications. Long-term outcomes included pregnancy and post-pregnancy complications for both mothers and infants.

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US).

Version: May 2008
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