Scheduled delivery may be preferable for women and their caregivers who place a very high priority on access to an epidural for analgesia or when there is a high risk of birth by cesarean delivery, so that general anesthesia can be avoided. For women who have no family history of VTE but have antithrombin deficiency or are homozygous for the prothrombin gene mutation, the ASH guideline panel suggests against using antepartum antithrombotic prophylaxis to prevent a first venous thromboembolic event (conditional recommendation, very low certainty in evidence about effects ⊕◯◯◯). 2002;99(6):1938-1942, Factor V Leiden mutation and the risk of venous thromboembolism in pregnant women. The observational studies in pregnancy described mortality, major bleeding, recurrent VTE, postthrombotic syndrome, and pregnancy loss. In the systematic review of outcomes in pregnant women receiving therapeutic anticoagulation for treatment of VTE, the incidence of major hemorrhage within 24 hours of delivery was 1.2% (95% CI, 0.3%-2.5%).31  The risk of blood loss at delivery >500 mL but ≤1000 mL was 13.5%, and loss >1000 mL but ≤1,500 mL was 0.4% in a multicenter hospital audit of 254 women who received therapeutic doses of tinzaparin.99  The risks were similar in the subgroup of patients who received tinzaparin within 24 hours of delivery. Although patients with life-threatening hemodynamic instability would most likely have been excluded from the relevant studies, the panel was of the opinion that this population would be most likely to benefit from systemic thrombolysis, and hence, a subgroup recommendation was made. The panel identified the following additional research need: the role of D-dimer testing and clinical prediction rules in limiting the need for radiologic tests in pregnant women with suspected pulmonary embolism needs to be evaluated in well-designed management studies. More data on estimated fetal radiation exposure and associated potential harms would be useful. Should outpatient therapy vs hospital admission be used in the initial treatment of pregnant patients with low-risk acute VTE? These guidelines provide recommendations on the use of risk assessment models, validated in … The EtD framework is shown online at: https://dbep.gradepro.org/profile/19ED27FD-6AA0-F63E-8C49-378C0C283BC2. There was no difference in the risk of postpartum hemorrhage after vaginal delivery in women whose last dose of therapeutic LMWH was less than 24 hours previously compared with those with a >24-hour time interval (OR, 1.3; 95% CI, 0.4-4.8). The panel recognized that the main causes of primary postpartum hemorrhage (the loss of ≥500 mL of blood from the genital tract within 24 hours of delivery) are uterine atony and trauma (although problems such as coagulation defects are also associated with excessive blood loss) and that bleeding secondary to the latter (eg, vaginal tears, episiotomy, and cesarean delivery) can be adversely affected by agents like LMWH that impair the hemostatic system. For pregnant women receiving prophylactic-dose LMWH, the ASH guideline panel suggests against scheduled delivery with discontinuation of prophylactic anticoagulation compared with allowing spontaneous labor (conditional recommendation, very low certainty in evidence about effects ⊕◯◯◯). 2015;103(1):33-34, Efficacy of low molecular weight heparin in patients undergoing in vitro fertilization or intracytoplasmic sperm injection, Adjunct low-molecular-weight heparin to improve live birth rate after recurrent implantation failure: a systematic review and meta-analysis, Low-dose aspirin therapy and hypertensive pregnancy complications in unselected IVF and ICSI patients: a randomized, placebo-controlled, double-blind study, Low-molecular-weight heparin in the treatment of recurrent IVF-ET failure and thrombophilia: a prospective randomized placebo-controlled trial. There were no differences in the incidence of major bleeding or wound hematoma between the 2 patient groups in the randomized trial that compared 2 enoxaparin dosing strategies after cesarean delivery in women with a body mass index of at least 35 kg/m2.204  Although the risk of major antepartum bleeding was not increased in women with thrombophilia randomly assigned to standard-dose followed by intermediate-dose LMWH prophylaxis compared with those allocated to no prophylaxis (3 [2.1%] of 143 vs 2 [1.4%] of 141; RR, 1.48; 95% CI, 0.25-8.72; 7 more per 1000, from 11 fewer to 110 more), the risk of minor antepartum bleeding was higher (28 [19.6%] of 143 vs 13 [9.2%] of 141; RR, 2.12; 95% CI, 1.15-3.93).57  One single-center observational study reported no episodes of major antepartum bleeding in 89 women receiving initial therapeutic followed by intermediate-dose LMWH or in 101 women receiving standard-dose prophylaxis.207  The risks of minor or minimal bleeding were similar in the 2 groups of patients (6 [6.7%] of 89 and 3 [3.0%] of 101; RR, 2.27; 95% CI, 0.59-8.81). Postpartum: For pregnant women who are homozygous for either factor V Leiden or the prothrombin gene mutation, suggest postpartum prophylaxis with prophylactic- or intermediate-dose LMWH, or vitamin K antagonists targeted at an INR of 2.0 to 3.0 for 6 weeks rather than routine care (regardless of family history) (grade 2B). The panel did not consider fondaparinux for first-line prophylaxis of VTE in pregnancy because this drug has been reported to cross the placenta in small amounts, and experience with fondaparinux in pregnancy (especially during the first trimester) is very limited.38,39  Vitamin K antagonists were not considered acceptable for prevention of pregnancy-associated VTE because it is known that these drugs cross the placenta and have the potential to cause teratogenicity, pregnancy loss, fetal bleeding, and neurodevelopmental deficits.40-44  Similarly, the oral direct thrombin and FXa inhibitors (ie, dabigatran, apixaban, edoxaban, and rivaroxaban) are likely to cross the placenta, and their reproductive toxicity in humans is unknown.45-48. J Obstet Gynaecol Can. Learn how patients, clinicians, policymakers, researchers, and others may interpret and apply guideline information. This document may also serve as the basis for adaptation by local, regional, or national guideline panels. We identified 1 single-center case series that compared outcomes in 2 consecutive groups of pregnant women receiving therapeutic LMWH therapy for acute VTE with and without anti-FXa level monitoring.69  There were several observational studies that examined the frequency of dosing alterations in pregnant women on anti-FXa–targeted LMWH therapy.64-68,70,71  There were no direct data, either randomized control trial or observational, that examined the effect of dose-adjusted treatment on mortality, postthrombotic syndrome, or chronic thromboembolic pulmonary hypertension specifically in pregnant patients. These guidelines focus on the optimal management of anticoagulant drugs for the prevention and treatment of VTE following the choice of an anticoagulant. [abstract]. However, with the low certainty in evidence, a single ultrasound at presentation should not be considered sufficient to rule out disease in pregnant women presenting with suspected DVT. Clinicians must make decisions on the basis of the clinical presentation of each individual patient, ideally through a shared process that considers the patient’s values and preferences with respect to the anticipated outcomes of the chosen option. Therefore, the panel was unable to make a recommendation for either the intervention or the comparator and instead considered that either is a reasonable option and that individual treatment decisions should be made using a shared decision-making model between the patient and clinician. For clinicians: different choices will be appropriate for individual patients, and clinicians must help each patient arrive at a management decision consistent with his or her values and preferences. In pregnant women who require prophylaxis, the ASH guideline panel suggests against intermediate-dose LMWH prophylaxis compared with standard-dose LMWH prophylaxis during the antepartum period (conditional recommendation, very low certainty in evidence about effects ⊕◯◯◯). This app is also available via web interface. J Clin Epidemiol. However, on the basis of the available evidence in this population and extrapolating from other populations as well as other EtD criteria, it is likely that the potential burdens and harms from prophylactic anticoagulation exceed potential health benefits in those with no or only 1 clinical risk factor for VTE. Introduction - GRADE evidence profiles and summary of findings tables [in German], Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study, Risk of a thrombotic event after the 6-week postpartum period, GRADE guidelines: 1. More data regarding patient values and preferences for the potential benefits and drawbacks of this intervention are required. For women without a family history of VTE who are heterozygous for the factor V Leiden mutation or prothrombin mutation or who have antithrombin, protein C, or protein S deficiency, the ASH guideline panel suggests against antithrombotic prophylaxis in the postpartum period to prevent a first venous thromboembolic event (conditional recommendation, very low certainty in evidence about effects ⊕◯◯◯). For women with a family history of VTE who are heterozygous for the factor V Leiden mutation or prothrombin mutation, the ASH guideline panel suggests against postpartum antithrombotic prophylaxis to prevent a first venous thromboembolic event (conditional recommendation, very low certainty in evidence about effects ⊕◯◯◯). In breastfeeding women who have an indication for anticoagulation, the ASH guideline panel recommends against using direct-acting oral anticoagulants (strong recommendation, very low certainty in evidence about effects ⊕◯◯◯). 1999;81(2):198-202, Incidence of venous thromboembolism in asymptomatic family members who are carriers of factor V Leiden: a prospective cohort study. However, this is based on low certainty in evidence because of issues related to observational study design. Given the available evidence, the guideline panel considered the risk of adverse effects most likely to be large. For each recommendation, the panel took a population perspective and agreed on the following: the certainty in the evidence, the balance of benefits and harms of the available management options, and the assumptions about the values and preferences associated with the decision. Despite these low absolute risks, pregnancy-associated VTE is a leading cause of maternal morbidity and mortality. The panel’s work was accomplished by using Web-based tools (www.surveymonkey.com and www.gradepro.org) and face-to-face and online meetings. The target audience includes patients, hematologists, obstetricians, maternal-fetal medicine specialists, general practitioners, internists, other clinicians, and decision makers. In breastfeeding women who have an indication for anticoagulation, the ASH guideline panel recommends using UFH, LMWH, warfarin, acenocoumarol, fondaparinux, or danaparoid as safe options (strong recommendation, low certainty in evidence about effects ⊕⊕◯◯). ASH is partnering with 13 societies to adapt the ASH VTE Clinical Practice Guidelines for Latin America. The panel considered the benefits of scheduled delivery, including the decreased risk for maternal bleeding. 2016;142:17-20, Feasibility of an easy-to-use risk score in the prevention of venous thromboembolism and placental vascular complications in pregnant women: a prospective cohort of 2736 women. 2017;377(23):2240-2252, Comparative outcomes of catheter-directed thrombolysis plus anticoagulation vs anticoagulation alone to treat lower-extremity proximal deep vein thrombosis, Catheter-directed thrombolysis for the management of postpartum deep venous thrombosis, Pharmacomechanical catheter-directed thrombolysis for pregnancy-related iliofemoral deep vein thrombosis, Ultrasound-accelerated catheter-directed thrombolysis for the management of postpartum deep venous thrombosis, Catheter-directed thrombolysis for thromboembolic disease during pregnancy: a viable option. 2 ):270-281, low-molecular-weight heparin ( LWMH ) over unfractionated heparin for of! 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