Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden, Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these practices. We therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
258
Women inject ourselves every days with 40 mg of enoxaparine
Women inject ourselves every days with placebo
Centre Hospitalier Universitaire de Brest
Brest, France
Centre Hospitalier Régional Universitaire de Caen
Caen, France
Centre Hospitalier Universitaire de Dijon
Dijon, France
Centre Hospitalier Bretagne Sud
Lorient, France
Centre Hospitalier Nord Marseille
Marseille, France
Centre Hospitalier Universitaire de Rouen
Rouen, France
Centre Hospitalier Universitaire de St Etienne
Saint-Etienne, France
Alive and Viable Births
Time frame: number of born child healthy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.