Journal of thrombosis and haemostasis : JTH · 2026
The role of antifactor Xa monitoring in the dosing and administration of low-molecular-weight heparins in pregnancy: a systematic review and meta-analysis.
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Ashraf Rizwana, Mohamed Dina, Sayfi Shahab, Bowen James M, Steinberg Irving, Shehata Nadine, Hwang Michelle, D'Souza Rohan
Аннотация
BACKGROUND: Low-molecular-weight heparins (LMWHs) are widely used in pregnancy for prevention and treatment of venous thromboembolism (VTE) and in individuals with mechanical heart valves (MHVs).
OBJECTIVES: Our aim was to determine the risk of thromboembolic complications (TECs) and major bleeding with weight-based, fixed, and anti-Xa-monitored dosing of LMWHs during pregnancy.
METHODS: We conducted a systematic review and searched 6 databases for articles published before August 2024 that reported on LMWH dosing and monitoring during pregnancy. We calculated event rates and 95% confidence intervals (95% CIs) for maternal death, TECs, and major bleeding using a random-effects meta-analysis. We assessed risk of bias using the Quality In Prognosis Studies tool and evaluated the certainty of evidence (CoE) using the Grading of Recommendations, Assessment, Development, and Evaluation approach.
RESULTS: We identified 5007 studies, of which 94 (53 case series, 30 cohort studies, and 11 randomized trials) were eligible. For thromboprophylaxis and VTE treatment, fixed, weight-based, and anti-Xa-monitored LMWH doses had overlapping pooled event rates and 95% CIs for TECs and major bleeding. For MHVs, the risk of maternal death, TECs, and major bleeding was 2.7% (95% CI, 0.3%-6.5%), 7.9% (95% CI, 2.8%-14.6%), and 8.4% (95% CI, 2.0%-17.2%), respectively with overlapping pooled single-arm event rates and 95% CIs across different anti-Xa-monitored LMWH dosing regimens. The CoE for all estimates was low to very low, mainly due to imprecision, risk of bias, and publication bias.
CONCLUSION: Pooled single-arm event rates and 95% CIs for the main outcomes overlapped across LMWH dosing regimens currently used in pregnancy for thromboprophylaxis, VTE treatment, and anticoagulation in individuals with MHVs. These findings should be interpreted in light of small sample sizes, wide 95% CIs, and low CoE; and not as evidence of comparable effectiveness or safety.
OBJECTIVES: Our aim was to determine the risk of thromboembolic complications (TECs) and major bleeding with weight-based, fixed, and anti-Xa-monitored dosing of LMWHs during pregnancy.
METHODS: We conducted a systematic review and searched 6 databases for articles published before August 2024 that reported on LMWH dosing and monitoring during pregnancy. We calculated event rates and 95% confidence intervals (95% CIs) for maternal death, TECs, and major bleeding using a random-effects meta-analysis. We assessed risk of bias using the Quality In Prognosis Studies tool and evaluated the certainty of evidence (CoE) using the Grading of Recommendations, Assessment, Development, and Evaluation approach.
RESULTS: We identified 5007 studies, of which 94 (53 case series, 30 cohort studies, and 11 randomized trials) were eligible. For thromboprophylaxis and VTE treatment, fixed, weight-based, and anti-Xa-monitored LMWH doses had overlapping pooled event rates and 95% CIs for TECs and major bleeding. For MHVs, the risk of maternal death, TECs, and major bleeding was 2.7% (95% CI, 0.3%-6.5%), 7.9% (95% CI, 2.8%-14.6%), and 8.4% (95% CI, 2.0%-17.2%), respectively with overlapping pooled single-arm event rates and 95% CIs across different anti-Xa-monitored LMWH dosing regimens. The CoE for all estimates was low to very low, mainly due to imprecision, risk of bias, and publication bias.
CONCLUSION: Pooled single-arm event rates and 95% CIs for the main outcomes overlapped across LMWH dosing regimens currently used in pregnancy for thromboprophylaxis, VTE treatment, and anticoagulation in individuals with MHVs. These findings should be interpreted in light of small sample sizes, wide 95% CIs, and low CoE; and not as evidence of comparable effectiveness or safety.