SPREE (version 1.0)
Research type
Research Study
Full title
Screening programme for pre-eclampsia
IRAS ID
192479
Contact name
Liona Poon
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Pre-eclampsia (PE) is a medical condition characterised by high blood pressure and the presence of protein in the urine of a pregnant woman. The effects of PE can be serious both for the mother and the baby, especially when the disease is severe requiring delivery before 37 weeks’ gestation (preterm-PE) and there is associated slow growth of the baby. Currently, obstetricians are guided by the NICE, which recommends to identify high-risk women based on maternal history but this approach identifies only 40% of women that develop preterm-PE and 35% of all-PE.
We have developed a new screening method for PE, combining maternal history, blood pressure, ultrasound assessment of blood flow to the uterus and two blood markers (PAPP-A and PlGF). A full combined test (history with 4 markers) can detect 75% and 55% for preterm-PE and all-PE, respectively . The respective detection rates for a mini-combined test (history with 2 markers) are 60% and 50%. Though the performance of the mini-combined test is lower, it is cheaper with no additional blood markers above standard of care. The primary aim of this study is to prospectively test the usefulness of our proposed new tests for PE screening, and compare to the NICE method.
This will be a multi-centre study. Maternal history and the 4 markers will be recorded. Eligible women will be recruited at the routine 11-13 weeks scan, and also record if the participants are taking aspirin or not. The same process will be repeated during their routine anomaly scan visit at 19-24 weeks'.
The primary outcome will be the wrongly classified positive cases and true positive cases for screening using the mini-combined method and the NICE method. It is anticipated that there will be an increase in detection rate for all PE from 35% (NICE method) to 50% (mini-combined test).
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/2161
Date of REC Opinion
22 Dec 2015
REC opinion
Further Information Favourable Opinion