COMPARATIVE TRIAL OF PREDNISONE PLUS ASPIRIN VERSUS ASPIRIN ALONE IN THE TREATMENT OF ANTICARDIOLIPIN ANTIBODY-POSITIVE OBSTETRIC PATIENTS

OBJECTIVE: We compared the use of aspirin alone with combined therapy (prednisone plus aspirin) in antiphospholipid antibody-positive obstet ric patients with prior adverse pregnancy outcome. STUDY DESIGN: Thirt y-nine patients meeting specific laboratory and clinical inclusion cri teria were randomized to receive either combined therapy (prednisone p lus low-dose aspirin, n = 17) or aspirin alone (n = 22). The daily asp irin dose was 81 mg; prednisone was begun at 20 mg/day and increased o r decreased on the basis of observed charges in serial antibody levels . Perinatal outcomes were compared between groups. Evaluation of treat ment-related maternal complications and serial antibody titers was als o accomplished. RESULTS: Thirty-four randomized subjects were evaluabl e (prednisone plus low-dose aspirin, n = 12 vs aspirin only, n = 22); no perinatal losses were observed in the study cohort. Preterm deliver y was experienced by significantly more patients receiving prednisone plus low-dose aspirin than aspirin only (8/12 vs 3/22, respectively; p = 0.003), and prednisone exposure appeared to be an independent risk factor for preterm birth. CONCLUSIONS: The use of prednisone therapy i n conjunction with low-dose aspirin does not appear to improve outcome and may provoke obstetric complications in antiphospholipid antibody- positive patients.