Prevention of Unexplained Recurrent Abortion by Enoxaparine (PREFIX)

Regional University Hospital Center (CHRU)

Status and phase: Terminated; Phase 3

Conditions: Alive and Viable Births

Treatments: Drug: placebo; Drug: enoxaparine 40 mg daily

Study type: Interventional

Funder types: Other

Identifiers

NCT00740545

RB06.050

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Drug: placebo

1

Experimental group

Treatment:

Drug: enoxaparine 40 mg daily