OBJECTIVE: To compare low-molecular-weight (LMW) heparin plus low-dose aspirin with intravenous immunoglobulin (IVIG) in the treatment of antiphospholipid antibody syndrome in women with recurrent spontaneous abortions before 10 weeks of gestation. METHOD: This prospective, multicenter trial conducted between 2002 and 2006 included 85 patients aged 18-39 years. The women were allocated randomly to receive LMW heparin plus low-dose aspirin, or IVIG. Data were compared using the t test and Fisher exact test. RESULTS: The women treated with LMW heparin plus low-dose aspirin had a higher rate of live births than those treated with IVIG (P=0.003). Of those who completed the study, 29/40 (72.5%) and 15/38 (39.5%), respectively, had live births. Intent-to-treat analysis revealed a significant difference between the 2 groups (OR 1.802; 95%CI, 1.14-2.84; P=0.007). CONCLUSIONS:LMW heparin plus low-dose aspirin resulted in a higher live birth rate than IVIG in the treatment of antiphospholipid antibody syndrome in women with recurrent abortion.
RCT Entities:
OBJECTIVE: To compare low-molecular-weight (LMW) heparin plus low-dose aspirin with intravenous immunoglobulin (IVIG) in the treatment of antiphospholipid antibody syndrome in women with recurrent spontaneous abortions before 10 weeks of gestation. METHOD: This prospective, multicenter trial conducted between 2002 and 2006 included 85 patients aged 18-39 years. The women were allocated randomly to receive LMW heparin plus low-dose aspirin, or IVIG. Data were compared using the t test and Fisher exact test. RESULTS: The women treated with LMW heparin plus low-dose aspirin had a higher rate of live births than those treated with IVIG (P=0.003). Of those who completed the study, 29/40 (72.5%) and 15/38 (39.5%), respectively, had live births. Intent-to-treat analysis revealed a significant difference between the 2 groups (OR 1.802; 95%CI, 1.14-2.84; P=0.007). CONCLUSIONS:LMW heparin plus low-dose aspirin resulted in a higher live birth rate than IVIG in the treatment of antiphospholipid antibody syndrome in women with recurrent abortion.
Authors: Silvia D'Ippolito; Riccardo Marana; Fiorella Di Nicuolo; Roberta Castellani; Manuela Veglia; John Stinson; Giovanni Scambia; Nicoletta Di Simone Journal: PLoS One Date: 2012-01-03 Impact factor: 3.240