Prevention of Unexplained Recurrent Abortion by Enoxaparine (PREFIX)

This study has been terminated.
(Stopped for futility)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740545
First received: August 22, 2008
Last updated: April 22, 2014
Last verified: April 2014
  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

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 ]

Enrollment: 258
Study Start Date: April 2007
Estimated Study Completion Date: September 2014
Primary Completion Date: September 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00740545

Locations
France
Centre Hospitalier Universitaire de Brest
Brest, France, 29609
Centre Hospitalier Régional Universitaire de Caen
Caen, France, 14033
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21079
Centre Hospitalier Bretagne Sud
Lorient, France
Centre Hospitalier Nord Marseille
Marseille, France, 13915
Centre Hospitalier Universitaire de Rouen
Rouen, France, 76031
Centre Hospitalier Universitaire de St Etienne
Saint Etienne, France
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: April 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 23, 2014