Prevention of Unexplained Recurrent Abortion by Enoxaparine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alive and Viable Births

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Women inject ourselves every days with placebo

1

Group Type EXPERIMENTAL

enoxaparine 40 mg daily

Intervention Type DRUG

Women inject ourselves every days with 40 mg of enoxaparine

Interventions

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enoxaparine 40 mg daily

Women inject ourselves every days with 40 mg of enoxaparine

Intervention Type DRUG

placebo

Women inject ourselves every days with placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No