Key result
Pregravid start of LMWH at high prophylactic doses in F2G20210A genotype carriers with prothrombin activity >171% reduced the absolute risk of pre-eclampsia by 46.7% (P=0.0001; NNT 2.1).
Why the study?
A prothrombin-mutant genotype is a recognized risk factor for gestational complications, but the efficacy of pregravid heparin prevention in females with the F2G20210A genotype and suprathreshold prothrombin activity required assessment.
Does low molecular-weight heparin prophylaxis prevent pre-eclampsia and foetal growth retardation in pregnant women with F2G20210A mutation and high prothrombin activity?
RCT (n=80)
randomized
No
Does low molecular-weight heparin prophylaxis prevent pre-eclampsia and foetal growth retardation in pregnant women with F2G20210A mutation and high prothrombin activity?
Absolute Risk Reduction: 46.7
Absolute Risk Reduction: 46.7%
Number Needed to Treat: 2.1
p-value: p=0.0001
Pregravid initiation of LMWH at high prophylactic doses significantly reduces the risk of pre-eclampsia and foetal growth retardation in pregnant women with the F2G20210A mutation and high prothrombin activity.
Hypothesis-generating for pregravid heparin in high-prothrombin F2G20210A carriers; larger trials needed before practice change.
Introduction. A prothrombin-mutant genotype is a known risk factor in gestational complications. Aim — efficacy assessment in pregravid heparin prevention of pre-eclampsia (PE) and foetal growth retardation (FGR) in females with F2G20210A genotype and suprathreshold prothrombin activity. Patients and methods. A single-centre randomised controlled study enrolled 80 pregnant women carrying prothrombin F2G20210A. The inclusion criterion was a pregravid plasma prothrombin activity > 171 %. The study cohort consisted of 50 women (mean age 31.2 ± 3.7 years) receiving low molecular-weight heparin (LMWH) in menstrual cycle at weight-based elevated prevention doses. A comparison group comprised 30 pregnant women (mean age 31.3 ± 2.9 years) not receiving LMWH prophylaxis. Results. A pregravid start of LMWH treatment at high prophylactic doses in F2G20210A genotype carriers with prothrombin activity > 171 % allowed an absolute risk reduction (ARR) of PE by 46.7 % [p = 0.0001; number needed to treat (NNT): 2.1; 95 % confidence interval (CI) 3.4–1.56], severe PE by 30.7 % [p = 0.0001; NTT: 3.3; 95 % CI (6.7–2.2)] and FGR by 30.7 % [p = 0.0001; NTT: 3.3; 95 % CI (6.7–2.2)]. Conclusion. Use of LMWH is justified in prevention of placenta-mediated complications in F2G20210A genotype carriers with a suprathreshold-high prothrombin activity.
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Nikolaeva et al. (2021) conducted an RCT in Pregnancy in F2G20210A mutation carriers with high prothrombin activity (n=80). Low molecular-weight heparin (LMWH) vs. No LMWH prophylaxis was evaluated on Pre-eclampsia (PE) (ARR 46.7%, p=0.0001). Pregravid start of LMWH at high prophylactic doses in F2G20210A genotype carriers with prothrombin activity >171% reduced the absolute risk of pre-eclampsia by 46.7% (P=0.0001; NNT 2.1).
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