Does aspirin have a role in improving pregnancy outcome for women with theantiphospholipid syndrome? A randomized controlled trial

OBJECTIVE: This pilot investigation was undertaken to assess the efficacy o f low-dose aspirin therapy for the treatment of women with antiphospholipid antibodies when recurrent miscarriage is the only sequels. STUDY DESIGN: A double-blind, randomized, placebo-controlled trial was cond ucted in the setting of the recurrent miscarriage clinic of a tertiary refe rral obstetric hospital. The participants were 50 women with a history of r ecurrent miscarriages (greater than or equal to3) and antiphospholipid anti bodies. Women with systemic lupus erythematosus or a history of thrombosis were excluded. Women were recruited after full investigative screening at t he recurrent miscarriage clinic. Women with greater than or equal to3 fetal losses and persistently positive results for antiphospholipid antibodies w ere randomly allocated to receive either aspirin (75 mg daily) or placebo. investigators, clinicians, and patients were blinded to the treatment. Rate s of live births, antenatal complications, and delivery and neonatal outcom es were recorded prospectively. Data were compared by chi (2) analysis with Yates' correction, the Fisher exact test, or the Student t test as appropr iate. RESULTS: There were 10 exclusions after random assignment because of inappr opriate inclusion. Eighty-five percent of the placebo (17/20) group and 80% of the aspirin-treated group (16/20) were delivered of live infants. This difference was not significant. There were no significant differences in an tenatal complications or neonatal morbidity between the groups. CONCLUSIONS: This preliminary study suggests that low-dose aspirin has no a dditional benefit when added to supportive care for women for whom recurren t early fetal loss is the only sequela of the antiphospholipid syndrome. Th is live birth rate with supportive care alone exceeds the published live bi rth rates for women with antiphospholipid antibody-mediated recurrent fetal loss who were treated with heparin or corticosteroids. This trial, like al l other trials in this field, is small, but its results bring into question the need for pharmacologic intervention for women with antiphospholipid sy ndrome for whom recurrent fetal loss is the only sequels. Our results highl ight the need for a large randomized controlled trial to identify the optim al treatment for this group of women and justify the inclusion of a placebo arm in any such trial.