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Addition of enoxaparin to aspirin for the secondary prevention of placental vascular complications in women with severe pre-eclampsiaThe pilot randomised controlled NOH-PE trial Financial support: This study was directly or indirectly supported by grants obtained from Baxter France, Bayer France, Becton Dickinson France, The Binding Site France, bioMérieux, Boehringer Ingelheim France, CSL Behring France, Dade Behring-Siemens France, Ferring pharmaceuticals France, Instrumentation Laboratory France, Leo Pharma France, Laboratoire Français du Fractionnement et des Biotechnologies, Novo Nordisk France, Octapharma France, Roche Diagnostics France, Sanofi-aventis France, Stago, Wyeth Pharmaceuticals France. The study was supported by an internal grant of the Clinical Research Committee of the University Hospital of Nîmes.
20 May 2011
Accepted after major revision: 19 August 2011
15 December 2017 (online)
dministration of heparin in the secondary prevention of placental vascular complications is still experimental. In women with a previous severe pre-eclampsia, we investigated the effectiveness of enoxaparin, a low-molecular-weight heparin, in preventing these complications. Between January 2000 and January 2010, 224 women from the NOHA First cohort, with previous severe pre-eclampsia but no foetal loss during their first pregnancy and negative for antiphospholipid antibodies, were randomised to either a prophylactic daily dose of enoxaparin starting from the positive pregnancy test (n=112), or no enoxaparin (n=112). The primary outcome was a composite of at least one of the following: pre-eclampsia, abruptio placentae, birthweight ≤5th percen-tile, or foetal loss after 20 weeks. Enoxaparin was associated with a lower frequency of primary outcome: 8.9% (n=10/112) vs. 25 % (28/112), p=0.004, hazard ratio = 0.32, 95% confidence interval (0.16–0.66), p=0.002. Enoxaparin was safe, with no obvious side-effect, no thrombocytopenia nor major bleeding event excess. This pilot study shows that enoxaparin given early during the second pregnancy decreases the occurrence of placental vascular complications in women with a previous severe pre-eclampsia during their first pregnancy.
The pilot randomised controlled NOH-PE trial
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