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Prevention of Unexplained Recurrent Abortion by Enoxaparine (PREFIX)

This study is currently recruiting participants.
Verified May 2011 by University Hospital, Brest
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740545
First received: August 22, 2008
Last updated: September 24, 2012
Last verified: May 2011
History of Changes
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Alive and Viable Births [ Time Frame: number of born child healthy ] [ Designated as safety issue: No ]

Estimated Enrollment: 610
Study Start Date: April 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 Drug: placebo
Women inject ourselves every days with placebo
Experimental: 1 Drug: enoxaparine 40 mg daily
Women inject ourselves every days with 40 mg of enoxaparine

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 18 and 45 years
  • 2 or more consecutive spontaneous abortions before the 15th week of pregnancy
  • Unexplained abortions
  • No maternal or paternal characterized chromosomal aberration
  • No Anti-phospholipid Syndrome
  • No anatomical abnormality possibly responsible for abortion
  • No Factor V Leiden
  • No Prothrombin G20210A mutation
  • No protein S deficiency
  • No protein C deficiency
  • No Anti thrombin 3 deficiency
  • Proved pregnancy

Exclusion Criteria:

  • Contraindications of enoxaparine 4000 U per day
  • Women with risk of venous thromboembolism during pregnancy
  • No regular anticoagulation or antiplatelet treatment
  • Blood Hemoglobin level below 10g/dl
  • Blood platelet level below 150 000/mm3
  • Creatinine clearance below 30ml/mn
  • Anomaly of the coagulation tests
  • No informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740545

Contacts
Contact: Elisabeth Pasquier, MD 33298347336 elisabeth.pasquier@chu-brest.fr

Locations
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 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 Bretagne Sud Recruiting
Lorient, France
Contact: Frédéric LECOMTE, Doctor            
Principal Investigator: Frédéric LECOMTE            
Centre Hospitalier Nord Marseille Recruiting
Marseille, France, 13915
Contact: Nathalie LESAVRE            
Principal Investigator: Nathalie LESAVRE            
Centre Hospitalier Universitaire de Rouen Recruiting
Rouen, France, 76031
Contact: Loïc MARPEAU            
Sub-Investigator: Eric VERSPYCK            
Principal Investigator: Loïc MARPEAU            
Centre Hospitalier Universitaire de St Etienne Recruiting
Saint Etienne, France
Contact: Céline CHAULEUR            
Principal Investigator: Céline CHAULEUR            
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Elisabeth Pasquier, MD Internal Medecine and pneumology department of university hospital of Brest (FRANCE)
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00740545     History of Changes
Other Study ID Numbers: RB06.050
Study First Received: August 22, 2008
Last Updated: September 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Enoxaparin
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013