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Background  There is now good evidence that antiplatelet agents (principally low dose aspirin) prevent pre-eclampsia, a leading cause of morbidity and mortality for pregnant women and their babies. A Cochrane Review identified moderate, but clinically important, reductions in the relative risks of pre-eclampsia (19%), preterm birth (7%) and perinatal mortality (16%) in women allocated antiplatelets, rather than placebo or no antiplatelet.  Uncertainty remains, however, about whether some women (in terms of risk) benefit more than others, what dose of aspirin is best and when in pregnancy treatment should ideally start. Rather than undertake new trials, the best way to answer these questions is to utilise existing individual patient data from women enrolled in each trial.    Methods/Design  Systematic review with meta-analysis based on individual patient data. This involves the central collection, validation and re-analysis of thoroughly checked data from individual women in all the available randomised trials.  The objective is to confirm that antiplatelet agents, given during pregnancy, will reduce the incidence of pre-eclampsia. The review will then determine the size of this effect, and whether antiplatelets delay the onset of pre-eclampsia or its impact on important outcomes for women and their babies. It will also explore whether the effect of antiplatelets differs by womens' risk profile; when commenced during pregnancy; and/or by dose.    Discussion  The PARIS (Perinatal Antiplatelet Review of International Studies) Collaboration has been formed to undertake the review. This will be the first individual patient data review in the perinatal field. Final results should be available by 2006–7.

Antiplatelet agents for prevention of pre-eclampsia and its consequences: a systematic review and individual patient data meta-analysis