Thousands of women to benefit from pre-eclampsia test

A new test that predicts with almost 100 percent accuracy that a pregnant woman will not develop pre-eclampsia within the following seven days is being fast-tracked for use across the NHS, sparing thousands of women nationwide a stressful hospital admission.

The test was successfully trialled by researchers and clinicians at Oxford University Hospitals (OUH) NHS Foundation Trust at the John Radcliffe Hospital's Women's Centre. After the trial, the test was accepted as routine clinical practice at OUH in 2018.

A paper on the INSPIRE study, which proved the efficacy of the test, was published on 12 August 2019 in the journal Hypertension. But the initiative is already being provided in numerous NHS trusts across the country.

The blood test, developed by Roche Diagnostics, measures the ratio of two placental factors - maternal serum soluble fms-like tyrosine kinase (sFlt-1) and placental growth factor (PlGF) - that are released into the mother's blood.

The test is used in conjunction with standard clinical practice. Following its adoption at OUH, as a result of close collaboration between Tim James, lab manager of Clinical Biochemistry at the Trust, and the research team at the University of Oxford, the Oxford Academic Health Science Network (AHSN) oversaw the introduction of the test into other hospitals in the Thames Valley region and beyond, through the AHSN Network.

The test has now been identified for rapid uptake nationally and is supported by the Innovation Technology Payment scheme and Accelerated Access Collaborative, which identifies highly transformative innovations and introduces an accelerated pathway to market.

Pre-eclampsia (PE) is a serious disease that occurs in around four percent of all pregnancies. It causes high blood pressure, protein in the urine and oedema and can result in liver failure, kidney failure and seizures in the mother. It can lead to restricted growth in the baby and often premature delivery.

Without the test, there is no accurate method to determine who will not get the disease. Currently, any patients with suspected PE are often admitted to hospital, sometimes for several days in order to make the diagnosis. PE is diagnosed by excluding all the other possible causes of high blood pressure and protein in the urine through a series of tests, which take time and cause anxiety for the mother-to-be and her family.

Before the introduction of the test at OUH, almost 70 percent of patients admitted did not actually have PE.

The additional cost to the NHS for treating pre-eclampsia is estimated at £9,000 per pregnancy.

Dr Sofia Cerdeira, a member of the research team, said: "This test has improved our ability to make the right decision on admission. Using the test, no one with pre-eclampsia within one week has been missed, so understandably, it has been welcomed enthusiastically by midwives and clinicians working here at the John Radcliffe Hospital's Women's Centre. We're delighted that it is being made available for women elsewhere in the country."

Dr Cerdeira, an OUH obstetrician registrar and Academic Clinical Lecturer at the University of Oxford's Nuffield Department of Women's & Reproductive Health, said: "One of the most important aspects of this test is that it allows the NHS to provide even better care for pregnant women and their babies. This means that thousands of women won't be admitted to hospital - often for several days - 'just in case' they may go on to develop pre-eclampsia, reducing the anxiety that that entails. This means that the right patients are being discharged, leaving us to focus on those women who are at greater risk of developing pre-eclampsia."

Rapid rollout of the test has been facilitated by the fact that special equipment is not required; the instruments are available at many hospital sites.

The test is a powerful example of how better diagnostics can leading to improvements in clinical care and system efficiencies. This was recognised when the initiative won the 'Best Healthcare Provider Partnership' category of the HSJ Partnership Awards 2019 and was awarded the international UNIVANTS of Healthcare Excellence prize in August 2019.

The test has proved so successful that it is now being introduced in other countries, including China, Japan, Sri Lanka, Canada, South Africa and Nigeria.