AspreCombined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-Based Pre-eclampsia Prevention.

Getting started with pre-eclampsia screening

One of PerkinElmer’s longstanding customers in Belgium answers questions on their experiences in setting up and implementing a pre-eclampsia screening program.

In starting a screening program for pre-eclampsia screening, what were the new laboratory needs?

There was no need for investment in instrument hard- and software or connections to the IT infrastructure; we were already using PerkinElmer tools, so we already had all instruments and connections to achieve useful analyzes to screen for pre-eclampsia. The only thing we had to install was a new app for the calculation of risk estimation.

With regard to the reporting infrastructure, we have always made our results communication as comprehensive as possible in the clinical report. For many years, the results of the three tests (for combined first trimester screening) were presented in the form of a table with the risks of trisomies 21 and 18, biochemical and combined. So we added a second table in which risk of early and late pre-eclampsia (before or after 34 weeks gestation) both anterior and posterior to the biochemical analyses is summarized.

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No need for instrument investment when labs already perform combined first trimester screening

A laboratory’s instrumentation requirements for pre-eclampsia screening are basically similar to those for combined first trimester screening. For the biochemistry tests in prenatal screening (PAPP-A and free hCGβ), measurement platforms widely used include PerkinElmer’s AutoDELFIA® high throughput batch analyzer, the semi-automatic DELFIA® system based on the VICTOR™ plate reader and the DELFIA Xpress random access system. Since PlGF is available on all three of the platforms mentioned, for their users it is a simple matter to run this test at the same time and in the same way as the other two. As well as keeping the investment cost low, there is also then a major saving in time and time-related testing costs.

Expert opinion
Emmanuel Bujold, Stéphanie Roberge

Aspirin for the prevention of pre-eclampsia

Over the last 30 years, there has been a huge controversy regarding the role of aspirin in the prevention of pre-eclampsia. We are now coming to the end of this journey that will hopefully end this debate.

In 1979, it was observed that women who had been taking aspirin during pregnancy were less likely to develop pre-eclampsia.(1) Following that observation, a French group decided to randomize women at high risk for pre-eclampsia and/or fetal growth restriction (FGR), mainly because of previous history, to receive aspirin 150 mg daily from 12 weeks gestation or no treatment.(2) They observed that aspirin reduced the risk of pre-eclampsia, FGR and perinatal death.

Following that study, more than 60 other randomized trials were performed, on more than 60,000 pregnant women. However, very few of them started the treatment in the first trimester, and they all used lower dosages (<150 mg) of aspirin, with contradictory results. In the meantime, new evidences was published regarding the high rate of aspirin resistance at dosage below 100 mg daily, (3) and that the optimal effect of aspirin, was when it was taken at bedtime.(4)

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recruitment

Expert opinion
Liona Poon

Project ASPRE was initially designed with 2 components – a screening study followed by a double blind randomised controlled trial (RCT) of aspirin vs. placebo in the prevention of preterm-PE.

During the internal pilot study it has been demonstrated that the randomised controlled trial has been successful with respect to recruitment to both the screening study and the randomised drug trial; however it has also highlighted the complexity of the main ASPRE RCT and confirmed the need for enhanced quality systems to be in place in advance of starting the trial in order to ensure the quality of pivotal data. Therefore, a screening quality study has been introduced to precede the main ASPRE trial. The aim of this screening quality study was to establish systems that would monitor quality in a more detailed, formalised manner at sites and use these systems to assess quality, identify areas for improvement and, where required, implement strategies to improve quality e.g. re-training. This is based on the DQASS system that has been successful for improving the quality of the ultrasound and biochemical measurements in the NHS fetal anomaly screening programme in the United Kingdom.

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Insight into pre-eclampsia:

ASPRE newsletter and website

The treatment and study of pre-eclampsia is evolving rapidly. That’s why PerkinElmer is launching a newsletter campaign and accompanying website to promote awareness of the latest advances in pre-eclampsia research and management.

We are also sharing the personal experience of healthcare staff and researchers involved in the ASPRE study.

During the course of the campaign, you will receive

  • Study progress bulletins and first access to ASPRE results
  • Exclusive interviews from healthcare experts and screening laboratories taking part in the study
  • Informative overviews on new approaches to pre-eclampsia treatment and management
  • Practical recommendations on how you can screen for pre-eclampsia more effectively