NCT00740545

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

6.4 years

First QC Date

August 22, 2008

Last Update Submit

March 4, 2015

Conditions

Alive and Viable Births

Outcome Measures

Primary Outcomes (1)

  • Alive and Viable Births

    number of born child healthy

Study Arms (2)

2

PLACEBO COMPARATOR
Drug: placebo

1

EXPERIMENTAL
Drug: enoxaparine 40 mg daily

Interventions

enoxaparine 40 mg dailyDRUG

Women inject ourselves every days with 40 mg of enoxaparine

1
placeboDRUG

Women inject ourselves every days with placebo

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 18 and 45 years
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Hospitalier Universitaire de Brest

Brest, 29609, France

Location

Centre Hospitalier Régional Universitaire de Caen

Caen, 14033, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21079, France

Location

Centre Hospitalier Bretagne Sud

Lorient, France

Location

Centre Hospitalier Nord Marseille

Marseille, 13915, France

Location

Centre Hospitalier Universitaire de Rouen

Rouen, 76031, France

Location

Centre Hospitalier Universitaire de St Etienne

Saint-Etienne, France

Location

Related Publications (1)

  • 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.

    PMID: 25636341DERIVED

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Elisabeth Pasquier, MD

    Internal Medecine and pneumology department of university hospital of Brest (FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

April 1, 2007

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

FR(7)