ALIFE2 study: Anticoagulants for living fetuses in women with recurrent miscarriage and inherited thrombophilia
The ALIFE2 study protocol has also been published in TRIALS (link here).
Women with a history of RM (2 or more not necessarily consecutive miscarriages), confirmed inherited thrombophilia and who are attempting to conceive or are less than 7 weeks pregnant will be recruited for the study. As soon as a urine pregnancy test is positive, they will be randomised to one of two groups. Women in group 1 will inject LMWH once daily, starting immediately after randomisation. To avoid peripartum hemorrage, LMWH will be discontinued at the beginning of labour. Women in group 2 will receive no intervention in addition to standard pregnancy surveillance.
The research population will be drawn from women with a history of RM and a positive test for either factor V Leiden, prothrombin gene mutation (G20210A), antithrombin deficiency, protein C deficiency or protein S deficiency, or a combination hereof.
Recruitment will take place in the Netherlands, as well as in several other countries, to be determined.
In the previous ALIFE study (Kaandorp, NEJM 2010), the occurrence of live birth in the subgroup of women who had an abnormal thrombophilia test and who became pregnant was 60% in those who were randomized to placebo. Based on this information, a conservative sample size assuming a live birth of 55% in the no treatment group is calculated. In order to detect an absolute risk difference of 15%, with a power of 80% and a two-sided confidence level of 95% (P<0.05), the sample size required for the study will be n=332, with in each arm 166 women. Taking a potential loss to follow up and exclusion from the study (due to ectopic pregnancy for example) into consideration, we aim to recruit 20% more women (n=399).
Planned duration of the study: three years
dr. M. Goddijn,gynecologist, Academic Medical Center, Amsterdam
Luuk Scheres, MD, PhD student
Department of vascular medicine
Academic Medical Center, University of Amsterdam
T: +31 20 5667516 / +31 71 5265635