LMWH does not result in higher live birth rates in women with inherited thrombophilia 

Low-molecular-weight heparin (LMWH) did not increase the live birth rate compared with standard-of-care in women with recurrent miscarriages and inherited thrombophilia, results from the ALIFE2 trial demonstrated.

The ALIFE study (ISRCTN58496168) suggested that LMWH, in combination with aspirin, may reduce recurrent miscarriage in women with inherited thrombophilia. To assess whether LMWH alone may decrease miscarriages in women with inherited thrombophilia, the randomised-controlled ALIFE2 study (NTR3361) was designed [1]. The trial, presented by Prof. Saskia Middeldorp (Radboud UMC, the Netherlands), included 326 women with inherited thrombophilia and a history of at least 2 miscarriages, who were actively trying to conceive or less than 7 weeks pregnant. The participants were randomised 1:1 to standard pregnancy care or to standard pregnancy care plus LMWH once daily until delivery. Aspirin was used as co-medication in 11% of the participants. The primary endpoint was the rate of live births.

The rate of live births was comparable for the 2 study arms (LMWH 71.6% vs control 70.9%; adjusted OR 1.08; P=0.770). Furthermore, the rate of adverse events was higher in the LMWH arm than in the control arm (43.9% vs 26.5%; OR 2.17; P=0.0016). According to Prof. Middeldorp, this difference was mostly caused by an increase of bruising, skin reaction at injection site, and minor bleedings in the experimental arm.

In conclusion, the authors do not advise to treat women with inherited thrombophilia with LMWH to prevent miscarriage.

1. Quenby S, et al. Low-Molecular-Weight Heparin Versus Standard Pregnancy Care for Women with Recurrent Miscarriage and Inherited Thrombophilia (ALIFE2): An Open-Label, Phase III Randomized Controlled Trial. Late-Breaking Abstract 5, ASH 64^th Annual Meeting, 10–13 December 2022, New Orleans, LA, USA.

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Posted on 20 February 2023