Prevention of Unexplained Recurrent Abortion by Enoxaparine

Study Overview
=================
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.

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

Conditions
-----------------
Alive and Viable Births

Intervention / Treatment
-----------------
* Drug: enoxaparine 40 mg daily
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br> | Drug: placebo<br>* Women inject ourselves every days with placebo<br>|
| Experimental: 1<br> | Drug: enoxaparine 40 mg daily<br>* Women inject ourselves every days with 40 mg of enoxaparine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive and Viable Births |  | number of born child healthy |