PREDNISONE AND ASPIRIN IN WOMEN WITH AUTOANTIBODIES AND UNEXPLAINED RECURRENT FETAL LOSS

Background Recurrent fetal loss has been well described in women with antiphospholipid antibodies. Such women also often have other autoanti bodies commonly found in patients with systemic lupus erythematosus. T reating them with prednisone and aspirin may reduce the risk of fetal loss. Methods We screened 773 nonpregnant women who had the unexplaine d loss of at least two fetuses for antinuclear, anti-DNA, antilymphocy te, and anticardiolipin antibodies and for the lupus anticoagulant. Of 385 women with at least one autoantibody, 202 who later became pregna nt were randomly assigned in equal numbers to receive either prednison e (0.5 to 0.8 mg per kilogram of body weight per day) and aspirin (100 mg per day) or placebo for the duration of the pregnancy. The women w ere stratified according to age (18 to 34 years or 35 to 39 years) and the week of gestation at which the previous fetal losses had occurred (less than or equal to 12 or >12 weeks). The primary outcome measure was a successful pregnancy. Results Live infants were born to 66 women in the treatment group (65 percent) and 57 women in the placebo group (56 percent, P=0.19). More infants were born prematurely in the treat ment group than in the placebo group (62 percent vs. 12 percent, P<0.0 01). The major side effects of therapy in the mothers were hypertensio n (treatment group, 13 percent; placebo group, 5 percent; P=0.05) and diabetes mellitus (15 percent and 5 percent, P=0.02). Conclusions Trea ting women who have autoantibodies and recurrent fetal loss with predn isone and aspirin is not effective in promoting live birth, and it inc reases the risk of prematurity. (C)1997, Massachusetts Medical Society .