Key result
A 14-day course of prophylactic LMWH in pregnant carriers of the FVL(1691)GA mutation reduced the absolute risk of pre-eclampsia by 29.5% (95% CI 2.3-56.12; P=0.0003).
Why the study?
Does a 14-day course of prophylactic LMWH reduce pregnancy complications in pregnant women with Factor V Leiden mutation and APC-resistance?
RCT (n=141)
randomized
No
Does a 14-day course of prophylactic LMWH reduce pregnancy complications in pregnant women with Factor V Leiden mutation and APC-resistance?
Absolute Risk Reduction: 29.5 (95% CI 2.3–56.12)
Absolute Risk Reduction: 29.5%
Number Needed to Treat: 3.4
p-value: p=0.0003
A 14-day course of prophylactic LMWH starting at 7-8 weeks of gestation significantly reduces the risk of pre-eclampsia, fetal growth retardation, and premature birth in pregnant women with Factor V Leiden mutation and APC-resistance.
Supports LMWH prophylaxis in Factor V Leiden pregnancies; extends RCT evidence for thromboprophylaxis in inherited thrombophilia.
The aim of the study was to determine the efficacy of heparin prophylaxis in preventing pregnancy complications in patients with the manifested laboratory phenotype – resistance to activated protein C (APC-resistance with NR ≤ 0.49) Factor V Leiden mutation (GA genotype). Materials and methods. A single-center, randomized, controlled trial of 141 pregnant women – carriers of the FVL(1691)GA mutation with APC-resistance ≤ 0.49 was determined at a gestation age of 7-8 weeks. Of these, 70 patients were included in the main group (mean age 30.2 ± 4.7 years); after the confirmation of the APC-resistance at 7-8 weeks of gestation, these women received a 14 day low-molecular-weight heparin (LMWH) course at elevated prophylactic doses. The comparison group (71 pregnant women of 30.3 ± 3.9 years old) received no LMWH. Results. The heparin prophylaxis (started from 7-8 weeks of gestation) at elevated doses in carriers of the FVL(1691)GA mutation with pronounced APC-resistance reduced the absolute risk (ARR) of pre-eclampsia by 29.5% (ARR: 29.5; p = 0.0003; NTT: 3.4; 95% Cl: 2.356.12), the risk of fetal growth retardation by 23.8% (ARR: 23.8; p = 0.0016; NTT: 4.2; 95% Cl: 2.8-8.7) and the risk of induced premature birth by 12.6% (ARR: 12.6; p = 0.0242; NTT: 5.8; 95% Cl: 3.7-14.1). Conclusion. The administration of LMWH at prophylactic doses for 14 days is indicated in patients with a manifested subclinical (laboratory) phenotype (APC-resistance with NR ≤ 0.49) of the FVL(1691)GA mutation starting from the gestation period of 7-8 weeks. If necessary (with a value of NR ≤ 0.49), it is advisable to repeat the courses of heparin prophylaxis at 18-19 and 27-28 weeks of pregnancy.
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Nikolaeva et al. (2018) conducted an RCT in Factor V Leiden mutation (GA genotype) with APC-resistance in pregnancy (n=141). Low-molecular-weight heparin (LMWH) vs. no LMWH was evaluated on Pre-eclampsia (ARR 29.5%, 95% CI 2.3-56.12, p=0.0003). A 14-day course of prophylactic LMWH in pregnant carriers of the FVL(1691)GA mutation reduced the absolute risk of pre-eclampsia by 29.5% (95% CI 2.3-56.12; P=0.0003).
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