title: Heparin in pregnant women with previous placenta-mediated pregnancy complications: a prospective, randomized, multicenter, controlled clinical trial.
abstract: To assess whether antithrombotic prophylaxis with low-molecular-weight heparin effectively prevents recurrence of late pregnancy complications, 135 women with previous history of preeclampsia, hemolytic anemia, elevated liver enzymes and low platelet count syndrome, intrauterine fetal death, fetal growth restriction, or placental abruption who had been referred within the 12th gestational week were randomized to medical surveillance alone (n = 68) or combined to open-label nadroparin (3800 IU daily subcutaneous injections) treatment (n = 67) in the setting of a randomized, parallel-group, superiority trial, run in Italy from April 2007 to April 2010. Primary outcome was a composite end point of late-pregnancy complications. Analysis was by intention to treat. The study was stopped for futility at the time of the first planned interim analysis. Among the 128 women eventually available for final analyses, 13 of the 63 (21%) randomized to nadroparin compared with 12 of the 65 (18%) on medical surveillance alone progressed to the primary end point. The absolute event risk difference between treatment arms (2.2; -1.6 to 16.0) was not statistically significant (P = .76). Thus, nadroparin did not prevent late-pregnancy complications in women at risk of recurrence. This finding challenges the role of antithrombotic prophylaxis with low-molecular-weight heparin in the prevention of recurrent late pregnancy complications The trial was registered at http://ricerca-clinica.agenziafarmaco.it as EudraCT 2006-004205-26.
authors.affiliation: A. Bianchi Bonomi Hemophilia and Thrombosis Center, Department of Medicine and Medical Specialties, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Ca' Granda-Ospedale Maggiore Policlinico, Via Pace 9, Milan, Italy. ida.martinelli@policlinico.mi.it.
authors.forename: Ida
authors.initials: I
authors.lastname: Martinelli
authors.forename: Piero
authors.initials: P
authors.lastname: Ruggenenti
authors.forename: Irene
authors.initials: I
authors.lastname: Cetin
authors.forename: Giorgio
authors.initials: G
authors.lastname: Pardi
authors.forename: Annalisa
authors.initials: A
authors.lastname: Perna
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vergani
authors.forename: Barbara
authors.initials: B
authors.lastname: Acaia
authors.forename: Fabio
authors.initials: F
authors.lastname: Facchinetti
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: La Sala
authors.forename: Maddalena
authors.initials: M
authors.lastname: Bozzo
authors.forename: Stefania
authors.initials: S
authors.lastname: Rampello
authors.forename: Luca
authors.initials: L
authors.lastname: Marozio
authors.forename: Olimpia
authors.initials: O
authors.lastname: Diadei
authors.forename: Giulia
authors.initials: G
authors.lastname: Gherardi
authors.forename: Sergio
authors.initials: S
authors.lastname: Carminati
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Pier Mannuccio
authors.initials: PM
authors.lastname: Mannucci
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D010920:Placenta / Q000473:pathology / Q000503:physiopathology; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight