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| Aspirin and/or low-molecular weight heparin for women with unexplained recurrent miscarriages and/or intra-uterine foetal death |
| ISRCTN | ISRCTN58496168 |
| ClinicalTrials.gov identifier | |
| Public title | Aspirin and/or low-molecular weight heparin for women with unexplained recurrent miscarriages and/or intra-uterine foetal death |
| Scientific title | |
| Acronym | ALIFE - Anticoagulants for Living Foetuses |
| Serial number at source | NTR206 |
| Study hypothesis |
There is reasonable evidence to suggest that some cases of recurrent pregnancy loss (RPL), including recurrent miscarriage (RM) and/or later intra-uterine foetal death, are associated with placental thrombosis and infarction. Approximately 5% of women experience two or more consecutive pregnancy losses. Recurrent miscarriage, defined as two or more spontaneous first trimester pregnancy losses, may affect as many as 1% to 2% of women of reproductive age. The prognosis in subsequent pregnancies of women with RM or late foetal death is a rate of live birth of approximately 65% and 50%, respectively, without any therapeutic intervention. Some haematologic conditions, such as the antiphospholipid syndrome (APLS) are associated with RPL. Compared to controls, women with familial thrombophilia, especially those with combined defects or antithrombin deficiency, have an increased risk of RM (odds ratio: 1.35) and late foetal death (odds ratio: 3.6).
Heparin and low-dose aspirin have been shown to be effective and safe in reducing the pregnancy loss rate in patients with APLS, with significantly better pregnancy outcome than low dose aspirin alone. While several non-randomised studies have suggested that anticoagulant therapy in women with RPL with or without thrombophilia may be of benefit resulting in an increased live birth rate, strong evidence based on randomised controlled trials is still lacking. The aim of the present trial is to evaluate the efficacy of different anticoagulant therapies in women with RPL with or without thrombophilia. |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Randomised, double-blind, placebo controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Unexplained recurrent miscarriages, intra-uterine foetal death |
| Participants - inclusion criteria | Women with at least two unexplained miscarriages and/or intra-uterine foetal deaths |
| Participants - exclusion criteria |
1. Previous thromboembolism
2. Antiphospholipid syndrome (APLS) 3. Uterine abnormalities 4. Patients’ or their partners’ abnormal karyotype 5. Indication for anticoagulant treatment during pregnancy (for instance prosthetic heart valves) 6. Metabolic and toxic factors (diabetes mellitus, radiation exposure) 7. Known erythrocyte antibody anti-P syndrome 8. Pregnancy losses due to documented foetal malformation or the result of an infectious complication 9. Known allergy to at least three different low-molecular-weight heparin (LMWH) preparations 10. Previous inclusion in the ALIFE trial (for another pregnancy) |
| Anticipated start date | 01/02/2004 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 300 |
| Interventions |
After inclusion in the study, patients will be randomised to the following groups:
1. Placebo 2. Aspirin (carbasalate calcium) 100 mg/day 3. Aspirin (carbasalate calcium) 100 mg/day plus low dose LMWH subcutaneously (s.c.) Placebo or low-dose aspirin is given from inclusion until 36 weeks of gestation. LMWH is given from 7 weeks gestation confirmed by foetal heartbeat throughout gestation. |
| Primary outcome measure(s) | Live birth rate |
| Secondary outcome measure(s) |
Prevalence of adverse pregnancy outcomes:
1. Pre-eclampsia 2. Haemolysis, elevated liver enzymes, low blood levels of platelets (HELLP) syndrome 3. Intra-uterine growth retardation 4. Premature delivery 5. Congenital malformations 6. Prevalence of thromboembolic and haemorragic complications 7. Thrombocytopaenia 8. Allergic reactions |
| Sources of funding |
1. Sanofi-Aventis (The Netherlands)
2. Academic Medical Centre (AMC) (The Netherlands) - Department of Vascular Medicine and Department of Obstetrics and Gynaecology 3. Viatris BV (The Netherlands) - manufacturer of carbasalate calcium |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20335572 |
| Contact name | Dr Saskia Middeldorp |
| Address |
Academic Medical Centre
Department of Vascular Medicine, F4-276 Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 5665976 |
| Fax | +31 (0)20 6968833 |
| alife@amc.uva.nl | |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address |
Department of Obstetrics and Gynaecology
Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 566 9111 |
| Sponsor website: | http://www.amc.uva.nl/ |
| Date applied | 20/12/2005 |
| Last edited | 05/05/2010 |
| Date ISRCTN assigned | 20/12/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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