Alive and Viable Births
Conditions
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.
Interventions
DRUGenoxaparine 40 mg daily
Women inject ourselves every days with 40 mg of enoxaparine
DRUGplacebo
Women inject ourselves every days with placebo
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alive and Viable Births | number of born child healthy |
Countries
France
Outcome results
None listed