Identified research priorities
| Treatment of acute VTE . |
|---|
| More data are required regarding the safety of fondaparinux and direct oral anticoagulants during pregnancy. |
| Further evidence should be sought regarding the risks, benefits, and acceptability of once-per-day vs twice-per-day LMWH dosing for treatment of acute VTE, specifically in the pregnant patient population. |
| Investigations should be performed to determine whether there is any benefit to twice-per-day dosing of LMWH for the treatment of VTE in the acute (ie, first month) setting, followed by de-escalation to once-per-day dosing for the remainder of the treatment period. |
| Larger and higher-quality studies that examine the role of anti-FXa monitoring in pregnant women receiving LMWH for treatment of acute VTE are required to obtain more precise estimates of effect. |
| Studies should be performed that evaluate the role of anti-FXa–level monitoring in the acute VTE treatment period followed by a standard weight-based dosing approach. |
| Studies should be performed that will provide pregnancy-specific data for stratifying risk for complications associated with treatment of VTE, and clinical prediction rules should be developed to identify pregnant patients who require hospital admission for initial management of DVT and pulmonary embolism. |
| Studies should be undertaken to examine the rates of hospital admission after outpatient VTE therapy has been initiated in pregnant patients. |
| More information is required from high-quality research on the safety and efficacy of catheter-directed thrombolysis in the pregnant population, including in those with limb-threatening DVT. |
| More data are required regarding patient values and preferences for the potential benefits and drawbacks of this catheter-directed thrombolysis for treatment of DVT in the pregnant population. |
| More data would be useful on estimated fetal radiation exposure and associated potential harms of catheter-directed thrombolysis for treatment of DVT during pregnancy. |
| More information is required from high-quality direct studies on the safety and efficacy of thrombolysis for pulmonary embolism in the pregnant population, including in those with submassive pulmonary embolism and right ventricular dysfunction alone. |
| More data are required on patient values and preferences for potential benefits and drawbacks of thrombolysis for pulmonary embolism during pregnancy. |
| Treatment of acute superficial vein thrombosis |
| More data are required regarding the dose and duration of LMWH if it is used in this context. |
| Management of anticoagulant therapy around the time of delivery |
| More outcome data would be helpful in examining different anticoagulant regimens at the time of delivery, including transitioning to intravenous UFH. |
| Data should be obtained that examines other critical outcomes for pregnant women with therapeutic anticoagulation interruption or prophylactic anticoagulation interruption around the time of delivery (including access to epidural analgesia and frequency of epidural hematomas, cesarean delivery, and maternal and neonatal morbidity and mortality). |
| Anticoagulant use in breastfeeding women |
| More data are required regarding the safety of the direct-acting oral anticoagulants in this population. |
| Prevention of VTE |
| More data are required regarding the baseline risk of VTE with assisted reproductive technology in specific patient populations, including those with prior VTE, thrombophilia, and other risk factors for VTE. |
| More data are required regarding the potential benefits and risks of antithrombotic therapy in reducing the risk of VTE and improving implantation outcomes in women using assisted reproductive technologies. |
| More data are required regarding optimal intensity of LMWH prophylaxis for the prevention of recurrent VTE during the antepartum and postpartum periods. The panel noted that the ongoing HIGHLOW study (Comparison of Low and Intermediate Dose Low-Molecular-Weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy; NCT 01828697) would provide valuable information once completed. |
| Further investigations should be performed to determine whether there are specific patient subgroups most likely to benefit from higher-dose prophylaxis. |
| Additional information would be helpful on the impact of thrombophilia status and precipitating risk factors with prior venous thromboembolic events on the risk of antepartum recurrent VTE. |
| More information should be gathered regarding optimal duration of postpartum prophylaxis. |
| Investigators should explore whether certain subgroups of patients with prior VTE are more likely to derive benefit from postpartum prophylaxis. |
| More data are required on patient values and preferences for antepartum and postpartum prophylaxis in women with thrombophilia. |
| Studies are needed examining the risks and benefits of antepartum and postpartum prophylaxis in women with thrombophilia. |
| More data should be gathered on the absolute risk of VTE with combinations of clinical risk factors. |
| Information would be helpful on the impact of applying clinical risk scoring systems and predictive models with respect to thrombosis prevention and bleeding risks as assessed by randomized trials. |
| Diagnosis of VTE |
| The role of D-dimer testing and clinical prediction rules in limiting the need for radiologic tests in pregnant women with suspected pulmonary embolism and suspected DVT needs to be evaluated in well-designed management studies. |
| More data are required on the safety of excluding DVT in pregnant women on the basis of a negative initial whole-leg compression ultrasound with imaging of the iliac veins. |
| Treatment of acute VTE . |
|---|
| More data are required regarding the safety of fondaparinux and direct oral anticoagulants during pregnancy. |
| Further evidence should be sought regarding the risks, benefits, and acceptability of once-per-day vs twice-per-day LMWH dosing for treatment of acute VTE, specifically in the pregnant patient population. |
| Investigations should be performed to determine whether there is any benefit to twice-per-day dosing of LMWH for the treatment of VTE in the acute (ie, first month) setting, followed by de-escalation to once-per-day dosing for the remainder of the treatment period. |
| Larger and higher-quality studies that examine the role of anti-FXa monitoring in pregnant women receiving LMWH for treatment of acute VTE are required to obtain more precise estimates of effect. |
| Studies should be performed that evaluate the role of anti-FXa–level monitoring in the acute VTE treatment period followed by a standard weight-based dosing approach. |
| Studies should be performed that will provide pregnancy-specific data for stratifying risk for complications associated with treatment of VTE, and clinical prediction rules should be developed to identify pregnant patients who require hospital admission for initial management of DVT and pulmonary embolism. |
| Studies should be undertaken to examine the rates of hospital admission after outpatient VTE therapy has been initiated in pregnant patients. |
| More information is required from high-quality research on the safety and efficacy of catheter-directed thrombolysis in the pregnant population, including in those with limb-threatening DVT. |
| More data are required regarding patient values and preferences for the potential benefits and drawbacks of this catheter-directed thrombolysis for treatment of DVT in the pregnant population. |
| More data would be useful on estimated fetal radiation exposure and associated potential harms of catheter-directed thrombolysis for treatment of DVT during pregnancy. |
| More information is required from high-quality direct studies on the safety and efficacy of thrombolysis for pulmonary embolism in the pregnant population, including in those with submassive pulmonary embolism and right ventricular dysfunction alone. |
| More data are required on patient values and preferences for potential benefits and drawbacks of thrombolysis for pulmonary embolism during pregnancy. |
| Treatment of acute superficial vein thrombosis |
| More data are required regarding the dose and duration of LMWH if it is used in this context. |
| Management of anticoagulant therapy around the time of delivery |
| More outcome data would be helpful in examining different anticoagulant regimens at the time of delivery, including transitioning to intravenous UFH. |
| Data should be obtained that examines other critical outcomes for pregnant women with therapeutic anticoagulation interruption or prophylactic anticoagulation interruption around the time of delivery (including access to epidural analgesia and frequency of epidural hematomas, cesarean delivery, and maternal and neonatal morbidity and mortality). |
| Anticoagulant use in breastfeeding women |
| More data are required regarding the safety of the direct-acting oral anticoagulants in this population. |
| Prevention of VTE |
| More data are required regarding the baseline risk of VTE with assisted reproductive technology in specific patient populations, including those with prior VTE, thrombophilia, and other risk factors for VTE. |
| More data are required regarding the potential benefits and risks of antithrombotic therapy in reducing the risk of VTE and improving implantation outcomes in women using assisted reproductive technologies. |
| More data are required regarding optimal intensity of LMWH prophylaxis for the prevention of recurrent VTE during the antepartum and postpartum periods. The panel noted that the ongoing HIGHLOW study (Comparison of Low and Intermediate Dose Low-Molecular-Weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy; NCT 01828697) would provide valuable information once completed. |
| Further investigations should be performed to determine whether there are specific patient subgroups most likely to benefit from higher-dose prophylaxis. |
| Additional information would be helpful on the impact of thrombophilia status and precipitating risk factors with prior venous thromboembolic events on the risk of antepartum recurrent VTE. |
| More information should be gathered regarding optimal duration of postpartum prophylaxis. |
| Investigators should explore whether certain subgroups of patients with prior VTE are more likely to derive benefit from postpartum prophylaxis. |
| More data are required on patient values and preferences for antepartum and postpartum prophylaxis in women with thrombophilia. |
| Studies are needed examining the risks and benefits of antepartum and postpartum prophylaxis in women with thrombophilia. |
| More data should be gathered on the absolute risk of VTE with combinations of clinical risk factors. |
| Information would be helpful on the impact of applying clinical risk scoring systems and predictive models with respect to thrombosis prevention and bleeding risks as assessed by randomized trials. |
| Diagnosis of VTE |
| The role of D-dimer testing and clinical prediction rules in limiting the need for radiologic tests in pregnant women with suspected pulmonary embolism and suspected DVT needs to be evaluated in well-designed management studies. |
| More data are required on the safety of excluding DVT in pregnant women on the basis of a negative initial whole-leg compression ultrasound with imaging of the iliac veins. |