title: 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.
abstract: 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.
authors.affiliation: Research team EA2992, Montpellier 1 University, Nîmes, France. jean.christophe.gris@chu-nimes.fr
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Gris
authors.forename: Céline
authors.initials: C
authors.lastname: Chauleur
authors.forename: Nicolas
authors.initials: N
authors.lastname: Molinari
authors.forename: Pierre
authors.initials: P
authors.lastname: Marès
authors.forename: Pascale
authors.initials: P
authors.lastname: Fabbro-Peray
authors.forename: Isabelle
authors.initials: I
authors.lastname: Quéré
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Lefrant
authors.forename: Bassam
authors.initials: B
authors.lastname: Haddad
authors.forename: Michel
authors.initials: M
authors.lastname: Dauzat
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D018450:Disease Progression; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D020073:Gravidity; D006801:Humans; D010865:Pilot Projects; D010920:Placenta / Q000473:pathology*; D011225:Pre-Eclampsia / Q000503:physiopathology*; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D001241:Aspirin