Objective: To explore the effects of interventions given to improve pregnancy outcome in women with antiphospholipid antibodies.
Data sources: Cochrane Controlled Trials Register, Cochrane Collaboration Pregnancy and Childbirth Group's Specialized Register of Controlled Trials, EMBASE, and MEDLINE were searched in December 1999.
Study selection: Randomized or quasi-randomized controlled trials of therapy for pregnancy loss associated with antiphospholipid antibodies were identified.
Tabulation, integration, and results: Trial selection, data extraction, and quality assessment were performed by two authors independently. Quantitative analysis of summary data was performed using the fixed- and random-effects models with heterogeneity assessments. Pregnancy loss and adverse neonatal outcomes were the main outcome measures. Ten trials (n = 627) fulfilled the inclusion criteria (of which four lacked adequate allocation concealment). Three trials of aspirin alone showed no significant reduction in pregnancy loss (relative risk [RR] 1.05, 95% confidence interval [CI] 0.66, 1.68). Heparin combined with aspirin (two trials, 140 patients) significantly reduced pregnancy loss compared with aspirin alone (RR 0.46, 95% CI 0.29, 0.71). Prednisone and aspirin resulted in a significant increase in prematurity (RR 4.83, 95% CI 2.85, 8.21) but no significant reduction in pregnancy loss (RR 0.85, 95% CI 0.53, 1.36).
Conclusion: Combination therapy with aspirin and heparin may reduce pregnancy loss in women with antiphospholipid antibodies by 54%. Further large, randomized controlled trials with adequate allocation concealment are necessary to exclude significant adverse effects.