The Comprehensive Clinical Trials Unit at UCL



19 December 2018

Combined multi-marker screening and randomised patient treatment with aspirin for evidence-based pre-eclampsia prevention.

In this multicentre trial women with singleton pregnancies undergoing routine prenatal screening at hospitals in the UK and five other countries were invited to participate in the screening study. Pregnant women were screened for preterm pre-eclampsia at 11 weeks 0 days - 13 weeks 6 days of gestation by a combination of maternal medical history and characteristics, maternal serum PAPP-A, PlGF, MAP and uterine artery PI. 

Women who were deemed to be at high-risk for preterm pre-eclampsia (11% of the population) were offered the opportunity to participate in the aspirin vs. placebo trial. Participants were randomized to one tablet per night of either aspirin 150 mg or matching placebo tablet from 11 - 14 weeks of gestation until 36 weeks of gestation.

26,941 women were screened and 1,766 randomised to this phase III two arm double-blinded randomised controlled trial to examine the effect of prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased risk for pre-eclampsia on the incidence and severity of the disease.  

Study status: Completed. The last participant completed the study in November 2016.


Trial registration: 
EudraCT 2013-003778-29