Trial reportTrials2015
ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia--study protocol for a randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 6 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Australasian recurrent pregnancy loss clinical management guideline 2024, part II.The Australian & New Zealand journal of obstetrics & gynaecology · 2024Guideline
- Pooled it
- Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period.The Cochrane database of systematic reviews · 2021Pooled it
- Safety and Efficacy of Enoxaparin in Pregnancy: A Systematic Review and Meta-Analysis.Advances in therapy · 2020Pooled it
- Care prior to and during subsequent pregnancies following stillbirth for improving outcomes.The Cochrane database of systematic reviews · 2018Pooled it
- Pregnancy, thrombophilia, and the risk of a first venous thrombosis: systematic review and bayesian meta-analysis.BMJ (Clinical research ed.) · 2017Pooled it
- LMWH prevents thromboinflammation in the placenta via HBEGF-AKT signaling.Blood advances · 2024Article
- Article
- Risk Factors of Thrombophilia-Related Mutations for Early and Late Pregnancy Loss.Medicina (Kaunas, Lithuania) · 2024Article
- Identifying discrepancies between clinical practice and evidence-based guideline in recurrent pregnancy loss care, a tool for clinical guideline implementation.BMC pregnancy and childbirth · 2023Article
- The Diagnostics and Treatment of Recurrent Pregnancy Loss.Journal of clinical medicine · 2023Review
- Recurrent Miscarriage: Diagnostic and Therapeutic Procedures. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry No. 015/050, May 2022).Geburtshilfe und Frauenheilkunde · 2023Article
- Doppler Ultrasound under Image Denoising Algorithm in the Diagnosis and Treatment of Fetal Growth Restriction Using Aspirin Combined with Low-Molecular-Weight Heparin.Journal of healthcare engineering · 2021Article
- Recurrent Miscarriage: Diagnostic and Therapeutic Procedures. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry Number 015/050).Geburtshilfe und Frauenheilkunde · 2018Article
- Maternal Thrombophilia and Recurrent Miscarriage - Is There Evidence That Heparin is Indicated as Prophylaxis against Recurrence?Geburtshilfe und Frauenheilkunde · 2018Article
- Challenges of Anticoagulation Therapy in Pregnancy.Current treatment options in cardiovascular medicine · 2017Review
- 'To test or not to test', the arguments for and against thrombophilia testing in obstetrics.Obstetric medicine · 2017Review
- Inherited thrombophilia: a double-edged sword.Hematology. American Society of Hematology. Education Program · 2016Review
- Prophylactic Anticoagulation With Intermediate-Dose Certoparin in Vascular-Risk Pregnancies-The PACER-VARP Registry.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisObservational
- Risk factors and role of low molecular weight heparin in obstetric complications among women with inherited thrombophilia - a cohort study.Hematology, transfusion and cell therapyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors at 19 institutions in 7 countries.
Funding
Abstract
backgroundA large number of studies have shown an association between inherited thrombophilia and recurrent miscarriage. It has been hypothesized that anticoagulant therapy might reduce the number of miscarriages and stillbirth in these women. In the absence of randomized controlled trials evaluating the efficacy of anticoagulant therapy in women with inherited thrombophilia and recurrent miscarriage, a randomized trial with adequate power that addresses this question is needed. The objective of the ALIFE2 study is therefore to evaluate the efficacy of low-molecular-weight heparin (LMWH) in women with inherited thrombophilia and recurrent miscarriage, with live birth as the primary outcome. METHODS/
designRandomized study of LMWH plus standard pregnancy surveillance versus standard pregnancy surveillance alone. STUDY POPULATION: pregnant women of less than 7 weeks' gestation, and confirmed inherited thrombophilia with a history of 2 or more miscarriages or intra-uterine fetal deaths, or both.
settingmulti-center study in centers from the Dutch Consortium of Fertility studies; centers outside the Netherlands are currently preparing to participate.
interventionLMWH enoxaparin 40 mg subcutaneously once daily started prior to 7 weeks gestational age plus standard pregnancy surveillance or standard pregnancy surveillance alone. Main study parameters/endpoints: the primary efficacy outcome is live birth. Secondary efficacy outcomes include adverse pregnancy outcomes, such as miscarriage, pre-eclampsia, syndrome of hemolysis, elevated liver enzymes and low platelets (HELLP syndrome), fetal growth restriction, placental abruption, premature delivery and congenital malformations. Safety outcomes include bleeding episodes, thrombocytopenia and skin reactions. DISCUSSION: After an initial period of slow recruitment, the recruitment rate for the study has increased. Improved awareness of the study and acknowledgement of the need for evidence are thought to be contributing to the improved recruitment rates. We aim to increase the number of recruiting centers in order to increase enrollment into the ALIFE2 study. The study website can be accessed via www.ALIFE2study.org.
trial registrationThe ALIFE2 study was registered on 19 March 2012 under registration number NTR3361.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.