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University Hospital, Brest |
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Information provided by: | University Hospital, Brest |
ClinicalTrials.gov Identifier: | NCT00740545 |
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.
Condition | Intervention | Phase |
---|---|---|
Alive and Viable Births |
Drug: enoxaparine 40 mg daily Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Essai thérapeutique randomisé Multicentrique en Double Insu, Comparant l'énoxaparine 40mg Versus Placebo, en Une Injection Sous-cutanée Quotidienne, Dans Les Fausses Couches spontanées récurrentes inexpliquées |
Estimated Enrollment: | 610 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator |
Drug: placebo
Women inject ourselves every days with placebo
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1: Experimental |
Drug: enoxaparine 40 mg daily
Women inject ourselves every days with 40 mg of enoxaparine
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elisabeth Pasquier, MD | 33298347336 | elisabeth.pasquier@chu-brest.fr |
France | |
Centre Hospitalier Universitaire de Brest | Recruiting |
Brest, France, 29609 | |
Contact: Elisabeth PASQUIER, Doctor elisabeth.pasquier@chu-brest.fr | |
Principal Investigator: Elisabeth PASQUIER | |
Sub-Investigator: Caroline BOHEC | |
Centre Hospitalier Bretagne Sud | Recruiting |
Lorient, France | |
Contact: Frédéric LECOMTE, Doctor | |
Principal Investigator: Frédéric LECOMTE | |
Centre Hospitalier Universitaire de St Etienne | Recruiting |
Saint Etienne, France | |
Contact: Céline CHAULEUR | |
Principal Investigator: Céline CHAULEUR | |
Centre Hospitalier Régional Universitaire de Caen | Recruiting |
Caen, France, 14033 | |
Contact: Michel DREYFUS | |
Principal Investigator: Michel DREYFUS | |
Sub-Investigator: Michel HERLICOVIEZ | |
Sub-Investigator: Christine DENOUAL-ZIAD | |
Centre Hospitalier Universitaire de Dijon | Recruiting |
Dijon, France, 21079 | |
Contact: Serge DOUVIER | |
Principal Investigator: Serge DOUVIER | |
Centre Hospitalier Universitaire de Rouen | Recruiting |
Rouen, France, 76031 | |
Contact: Loïc MARPEAU | |
Sub-Investigator: Eric VERSPYCK | |
Principal Investigator: Loïc MARPEAU | |
Centre Hospitalier Nord Marseille | Recruiting |
Marseille, France, 13915 | |
Contact: Nathalie LESAVRE | |
Principal Investigator: Nathalie LESAVRE |
Principal Investigator: | Elisabeth Pasquier, MD | Internal Medecine and pneumology department of university hospital of Brest (FRANCE) |
Responsible Party: | EA 3878 ( Dr Elisabeth Pasquier ) |
Study ID Numbers: | Brest University Hospital |
Study First Received: | August 22, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00740545 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Abortion, Habitual Recurrence Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |