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Prevention of Unexplained Recurrent Abortion by Enoxaparine (PREFIX)

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ClinicalTrials.gov Identifier: NCT00740545
Recruitment Status : Terminated (Stopped for futility)
First Posted : August 25, 2008
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE August 22, 2008
First Posted Date  ICMJE August 25, 2008
Last Update Posted Date March 5, 2015
Study Start Date  ICMJE April 2007
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
Alive and Viable Births [ Time Frame: number of born child healthy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00740545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Unexplained Recurrent Abortion by Enoxaparine
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alive and Viable Births
Intervention  ICMJE
  • Drug: enoxaparine 40 mg daily
    Women inject ourselves every days with 40 mg of enoxaparine
  • Drug: placebo
    Women inject ourselves every days with placebo
Study Arms  ICMJE
  • Placebo Comparator: 2
    Intervention: Drug: placebo
  • Experimental: 1
    Intervention: Drug: enoxaparine 40 mg daily
Publications * Pasquier E, de Saint Martin L, Bohec C, Chauleur C, Bretelle F, Marhic G, Le Gal G, Debarge V, Lecomte F, Denoual-Ziad C, Lejeune-Saada V, Douvier S, Heisert M, Mottier D. Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial. Blood. 2015 Apr 2;125(14):2200-5. doi: 10.1182/blood-2014-11-610857. Epub 2015 Jan 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 22, 2014)
258
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2008)
610
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740545
Other Study ID Numbers  ICMJE RB06.050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elisabeth Pasquier, MD Internal Medecine and pneumology department of university hospital of Brest (FRANCE)
PRS Account University Hospital, Brest
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP