Status:
TERMINATED
Prevention of Unexplained Recurrent Abortion by Enoxaparine
Lead Sponsor:
University Hospital, Brest
Conditions:
Alive and Viable Births
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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 mu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00740545
Start Date
April 1 2007
End Date
September 1 2014
Last Update
March 5 2015
Active Locations (7)
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1
Centre Hospitalier Universitaire de Brest
Brest, France, 29609
2
Centre Hospitalier Régional Universitaire de Caen
Caen, France, 14033
3
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21079
4
Centre Hospitalier Bretagne Sud
Lorient, France