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ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial

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Title
ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial
Published in
Trials, May 2015
DOI 10.1186/s13063-015-0719-9
Pubmed ID
Authors

Paulien G de Jong, Siobhan Quenby, Kitty WM Bloemenkamp, Babette AM Braams-Lisman, Jan Peter de Bruin, Arri Coomarasamy, Michele David, Maria T DeSancho, Olivier WH van der Heijden, Annemieke Hoek, Barbara A Hutten, Kristin Jochmans, Carolien AM Koks, Walter KH Kuchenbecker, Ben Willem J Mol, Helen L Torrance, Hubertina CJ Scheepers, Mary D Stephenson, Harold R Verhoeve, Jantien Visser, Johanna IP de Vries, Mariëtte Goddijn, Saskia Middeldorp

Abstract

A 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. Randomized study of LMWH plus standard pregnancy surveillance versus standard pregnancy surveillance alone. 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. multi-center study in centers from the Dutch Consortium of Fertility studies; centers outside the Netherlands are currently preparing to participate. LMWH 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. 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 . The ALIFE2 study was registered on 19 March 2012 under registration number NTR3361.

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 144 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 <1%
Spain 1 <1%
Denmark 1 <1%
Unknown 141 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 30 21%
Student > Ph. D. Student 17 12%
Student > Bachelor 17 12%
Researcher 10 7%
Professor 8 6%
Other 29 20%
Unknown 33 23%
Readers by discipline Count As %
Medicine and Dentistry 59 41%
Nursing and Health Professions 11 8%
Biochemistry, Genetics and Molecular Biology 5 3%
Psychology 4 3%
Immunology and Microbiology 3 2%
Other 18 13%
Unknown 44 31%