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Addition of enoxaparin to aspirin for the secondary prevention of placental vascular complications in women with severe pre-eclampsia

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH11-05-0340
Issue: 2011: 106/6 (Dec) pp. 993-1234
Pages: 1053-1061

Addition of enoxaparin to aspirin for the secondary prevention of placental vascular complications in women with severe pre-eclampsia

The pilot randomised controlled NOH-PE trial

J.-C. Gris (1, 2, 3), C. Chauleur (4, 5), N. Molinari (6), P. Marès (7), P. Fabbro-Peray (6), I. Quere (8), J.-Y. Lefrant (9, 3), B. Haddad (10), M. Dauzat (11)

(1) Haematology Laboratory, University Hospital, Nîmes, France; (2) Haematology Laboratory, Faculty of Pharmacy and Biological Sciences, University Hospital, Nîmes, France; (3) Research Unit 2992, University Hospital, Nîmes, France; (4) Research team EA2992, Montpellier 1 University, Nîmes, France; (5) Department of Gynaecology and Obstetrics, University Hospital, Saint-Etienne, France; (6) Department of Biostatistics and Epidemiology, University Hospital, Nîmes, France; (7) Department of Obstetrics and Gynaecology, University Hospital, Nîmes, France; (8) Department of Vascular Medicine, University Hospital, Montpellier, France; (9) Central intensive care unit, University Hospital, Nîmes, France; (10) Department of Obstetrics and Gynaecology, Paris XII University, Créteil, France; (11) Department of Vascular Medicine, University Hospital, Nîmes, France

Keywords

Randomised Controlled Trial, pregnancy, pre-eclampsia, placental vascular complications, low-, molecular-weight heparin

Summary

Administration 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 percentile, 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.

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