Protocol for the prospective validation study: ‘Screening programme for pre‐eclampsia’ (SPREE)

What is it about?

Pre-eclampsia (PE) is a disorder of pregnancy characterised by high blood pressure and often protein in the urine. It affects about 2% of pregnancies and is associated with complications including impaired liver function, kidney dysfunction, bleeding, fetal growth restriction; if left untreated it may result in seizures or even death. Currently the National Institute for Health and Clinical Excellence (NICE) recommends identification of women at high risk of developing PE by checking their medical history at their booking visit. This method of screening is poor as it identifies only 35% of women who subsequently have PE. An alternative way of screening for PE can be achieved by a combination of maternal characteristics and medical history together with the measurements of blood pressures, ultrasound of blood flows to the placenta in combination with blood hormone levels at 11-13 weeks' gestation. This method is estimated to detect 55% of women who develop PE, and 75% of those with PE requiring preterm delivery. The aim of the study is to compare screening for PE using current NICE guidelines versus screening using a novel method. This is a prospective multicenter cohort study in seven NHS hospitals with a target sample size of 16,850 pregnancies. All women with singleton pregnancies attending their routine 11-13 weeks’ scan are invited to participate. The primary outcome will be the effectiveness of screening of PE using the combined method versus NICE guideline.

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