Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia
Chief Investigator: Professor Siobhan Quenby
Sponsor: University Hospitals Coventry and Warwickshire
Funder: Research for Patient Benefit (RfPB)
Registration Number: EudraCT 2015-002357-35
ALIFE 2 is a multi-centre randomised clinical trial to compare Low Molecular Weight Heparin (LMWH) with standard pregnancy surveillance in women with inherited thrombophilia (a blood clotting problem) and a history of recurrent miscarriage (RM).
Women with a history of RM (2 or more not necessarily consecutive miscarriages or intra-uterine foetal deaths), confirmed inherited thrombophilia and who are attempting to conceive or are less than 7 weeks pregnant (based on first day of last menstruation) will be registered onto the study.
Participants will be randomised to one of two groups. Participants in group 1 will inject LMWH once daily, starting immediately after randomisation. LMWH will be discontinued at the beginning of labour.
Participants in group 2 will receive no intervention in addition to standard pregnancy surveillance.
The trial sample size calculations have included patients being recruited in the Netherlands ALIFE2 trial. The Netherlands ALIFE2 trial also have oversight of recruitment for the ALIFE2 Trial in the USA and Belgium, Slovenia and Canada, this is independent of the UK component of the trial.
The international sample size for the ALIFE trial is 400 registered participants.
The UK will register 300 patients into the ALIFE2 trial.