Clinical trial NCT00740545: Prevention of Unexplained Recurrent Abortion by Enoxaparine
Official title: Essai thérapeutique randomisé Multicentrique en Double Insu, Comparant l'énoxaparine 40mg Versus Placebo, en Une Injection Sous-cutanée Quotidienne, Dans Les Fausses Couches spontanées récurrentes inexpliquées
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alive and Viable Births
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Alive and Viable Births
timeFrame: number of born child healthy
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalier Universitaire de Brest
city: Caen
country: France
facility: Centre Hospitalier Régional Universitaire de Caen
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Marseille
country: France
facility: Centre Hospitalier Nord Marseille
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire de St Etienne
Study officials:
affiliation: Internal Medecine and pneumology department of university hospital of Brest (FRANCE)
name: Elisabeth Pasquier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasquier E, de Saint Martin L, Bohec C, Chauleur C, Bretelle F, Marhic G, Le Gal G, Debarge V, Lecomte F, Denoual-Ziad C, Lejeune-Saada V, Douvier S, Heisert M, Mottier D. Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial. Blood. 2015 Apr 2;125(14):2200-5. doi: 10.1182/blood-2014-11-610857. Epub 2015 Jan 30.