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Prevention of Unexplained Recurrent Abortion by Enoxaparine

NCT00740545 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2015-03-05

No results posted yet for this study

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.

Conditions

  • Alive and Viable Births

Interventions

DRUG

enoxaparine 40 mg daily

Women inject ourselves every days with 40 mg of enoxaparine

DRUG

placebo

Women inject ourselves every days with placebo

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Elisabeth Pasquier, MD · Internal Medecine and pneumology department of university hospital of Brest (FRANCE)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2013-09-30
Completion
2014-09-30

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00740545 on ClinicalTrials.gov