Prevention of Unexplained Recurrent Abortion by Enoxaparine (NCT00740545) | Clinical Trial Compass
TerminatedPhase 3
Prevention of Unexplained Recurrent Abortion by Enoxaparine
Stopped: Stopped for futility
France258 participantsStarted 2007-04
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.