Alive and Viable BirthsPhase 3PREFIXNCT00740545
Prevention of Unexplained Recurrent Abortion by Enoxaparine
A Phase 3 study testing enoxaparine 40 mg daily in people with Alive and Viable Births, run by University Hospital, Brest at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Alive and Viable Births
- What is being tested?
- enoxaparine 40 mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 7 sitesFrance
- Study dates
- Apr 2007to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- No Factor V Leiden
- No Prothrombin G20210A mutation
- No protein S deficiency
- No protein C deficiency
- No Anti thrombin 3 deficiency
- Proved pregnancy
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalier Universitaire de Brest
Brest, 29609
Centre Hospitalier Régional Universitaire de Caen
Caen, 14033
Centre Hospitalier Universitaire de Dijon
Dijon, 21079
Centre Hospitalier Bretagne Sud
Lorient
Centre Hospitalier Nord Marseille
Marseille, 13915
Centre Hospitalier Universitaire de Rouen
Rouen, 76031
Centre Hospitalier Universitaire de St Etienne
Saint-Etienne
About this study
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
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.
- Conditions
- Alive and Viable Births
- Being tested
- enoxaparine 40 mg daily, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparine 40 mg dailyDrug
Women inject ourselves every days with 40 mg of enoxaparine
placeboDrug
Women inject ourselves every days with placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
| 1 | Experimental | Not described Receives: Drug: enoxaparine 40 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive and Viable Births
Measured: number of born child healthy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startApr 2007
- Primary completionSep 2013
- Study completionSep 2014
Why it stopped: Stopped for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alive and Viable BirthsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Pasquier, MD, Principal investigator, Internal Medecine and pneumology department of university hospital of Brest (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740545
- Sponsor's protocol ID
- RB06.050
- Acronym
- PREFIX
- Status last verified
- Mar 2015
- First submitted
- 22 Aug 2008
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25636341
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00740545
- Acronym / sponsor ID
- PREFIX / RB06.050
- Conditions
- Alive and Viable Births
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped for futility
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placebo |
| 1 | Experimental | Drug: enoxaparine 40 mg daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enoxaparine 40 mg dailyWomen inject ourselves every days with 40 mg of enoxaparine | Drug | 1 |
| placeboWomen inject ourselves every days with placebo | Drug | 2 |
Primary outcome
Alive and Viable Births
Time frame: number of born child healthy
Results and safety
The study was stopped early (reason given: Stopped for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Derived from this study: PubMed 25636341Pasquier 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Pasquier, MD principal investigator
Internal Medecine and pneumology department of university hospital of Brest (FRANCE)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing enoxaparine 40 mg daily in people with Alive and Viable Births, run by University Hospital, Brest at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Stopped for futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive and Viable Births (time frame: number of born child healthy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.