Treatment of antiphospholipid syndrome in pregnancy—a systematic review of randomized therapeutic trials

A comprehensive literature search identified 13 randomized or quasi-randomized therapeutic trials of obstetric antiphospholipid syndrome (aPL) syndrome and all but one are appraised. Several overriding problems with trial design were evident: (i) small trial size, (ii) absence of blinding, (iii) lack of no treatment arms and (iv) highly variable entry criteria, treatments and endpoint definitions leading to trial clinical heterogeneity. Low-dose aspirin and heparin is recommended for obstetric antiphospholipid syndrome but the evidentiary basis for this remains weak. There is no evidence to support treatment with intravenous immunoglobulin or prednisone. Ideally, co-operative large fully blinded placebo controlled randomized trials of therapy in patients with obstetric aPL stratified by different levels of risk are still required.