Thromb Haemost 2011; 106(06): 1053-1061
DOI: 10.1160/TH11-05-0340
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

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
Jean-Christophe Gris
1   Research team EA2992, Montpellier 1 University, Nîmes, France
2   Laboratory of Haematology, University Hospital, Nîmes, France
3   Faculty of Biological and Pharmaceutical Sciences, Montpellier, France
,
Céline Chauleur
1   Research team EA2992, Montpellier 1 University, Nîmes, France
4   Department of Gynaecology and Obstetrics, University Hospital, Saint-Etienne, France
,
Nicolas Molinari
5   Department of Biostatistics and Epidemiology, University Hospital, Nîmes, France
,
Pierre Marès
6   Department of Obstetrics and Gynaecology, University Hospital, Nîmes, France
,
Pascale Fabbro-Peray
5   Department of Biostatistics and Epidemiology, University Hospital, Nîmes, France
,
Isabelle Quéré
7   Department of Vascular Medicine, University Hospital, Montpellier, France
,
Jean-Yves Lefrant
8   Department of Intensive Care Unit, University Hospital, Nîmes, France
,
Bassam Haddad
9   Department of Obstetrics and Gynaecology, Paris XII University, Créteil, France
,
Michel Dauzat
10   Department of Vascular Medicine, University Hospital, Nîmes, France
› Author Affiliations
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.
Further Information

Publication History

Received: 20 May 2011

Accepted after major revision: 19 August 2011

Publication Date:
15 December 2017 (online)

Summary

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