Prevention of Unexplained Recurrent Abortion by Enoxaparine

Phase 3

Terminated

• Conditions: Alive and Viable Births
• Interventions: Drug: placebo; Drug: enoxaparine 40 mg daily

• Registration Number: NCT00740545
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Primary Completion: 2013-09
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	enoxaparine 40 mg daily	-

Primary Outcome Measures

Name	Time	Method
Alive and Viable Births	number of born child healthy

Trial Locations

Locations (7)

Centre Hospitalier Régional Universitaire de Caen; 🇫🇷 Caen, France

Centre Hospitalier Universitaire de Brest; 🇫🇷 Brest, France

Centre Hospitalier Universitaire de Dijon; 🇫🇷 Dijon, France

Centre Hospitalier Nord Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Bretagne Sud; 🇫🇷 Lorient, France

Centre Hospitalier Universitaire de Rouen; 🇫🇷 Rouen, France

Centre Hospitalier Universitaire de St Etienne; 🇫🇷 Saint Etienne, France