UK’s NHS to Distribute New Clinical Laboratory Test for Women Suspected of Having Pre-Eclampsia
Based on clinical trials of the medical laboratory test, pregnant women can expect a reduced risk for experiencing complications associated with the dangerous blood disorder Clinical pathology laboratories and obstetricians in the UK may soon have a new blood test that can help provide earlier diagnoses of pre-eclampsia, a hypertensive disorder of pregnancy that can cause liver and kidney disfunctions and, if untreated, can lead to eclampsia and deadly seizures. Following a clinical trial conducted by scientists at King’s College London (King’s College), the National Health Service (NHS) in the United
Kingdom (UK) announced it would be making the new test widely available. The researchers published their findings in The
Lancet medical journal. Their paper explains that the clinical trial
took place in 11 maternity units in the UK from June 2016 through October 2017.
And that 1,023 women were divided into two groups: The researchers, the Independent
reported, wanted to determine the impact, if any, the new test’s results would
have on diagnoses. Significantly Reduced Time to Diagnosis Trial results indicated that measuring the placental growth factor (PGF) in women who are suspected of having pre-eclampsia can increase speed to diagnosis. “PGF testing was shown to reduce the average time to pre-eclampsia diagnosis from 4.1 days to 1.9 days, and serious complications before birth (such as eclampsia, stroke, and maternal death) [dropped] from 5% to 4%,” a King’s College press release stated. “Complications like stroke, seizures and maternal death fell
by 20% when doctors had access to PGF testing,” the Independent
reported. The researchers stated in their study, “Our trial has shown
that, in women presenting with suspected pre-eclampsia, PGF measurement,
incorporated into a management algorithm based on national guidelines,
significantly reduces the time taken for treating clinicians to diagnose
pre-eclampsia. This improvement was associated with a significant reduction in
maternal adverse outcomes, with no detected difference in gestational age at
delivery or adverse perinatal outcomes.” The King’s College press release states, “Pre-eclampsia is
suspected in around 10% of UK pregnancies, affecting approximately 80,000 women
annually. If untreated, it can progress to cause complications in the woman,
including damage to vital organs, fits, and can be fatal for the woman and
baby. Globally, 100 women die as a result of the condition every day.” The release also noted that “doctors were able to diagnose
pre-eclampsia on average two days sooner. This was associated with significant
improvements in outcomes for women without causing health problems for babies.” Measuring PGF in Clinical Laboratory Study PGF is a molecular marker for inflammation associated mostly
with the mother’s placenta.
The King’s College researchers wanted to find out if a quicker diagnosis of
pre-eclampsia was possible. And, if so, could it reduce adverse outcomes in the
mother and baby? “For the last hundred years, we have diagnosed pre-eclampsia
through measuring blood pressure and checking for protein in a woman’s urine.
These are relatively imprecise and often quite subjective,” said Lucy Chappell, PhD,
NIHR Research Professor in Obstetrics at King’s College, and lead author of the
study, in the news release. “We knew that monitoring PGF was an accurate way to help
detect the condition, but [we] were unsure whether making this tool available
to clinicians would lead to better care for women. Now we know that it does,” she
concluded. Pre-eclampsia can lead to stroke, seizures, and even death
of expectant mothers and unborn children. It is usually diagnosed after 20
weeks of gestation through blood pressure tests and urine tests that show
hypertension and elevated protein levels. “We found that the availability of PGF test results
substantially reduced the time to clinical confirmation of pre-eclampsia. Where
PGF was implemented, we found a lower incidence of maternal adverse outcomes,”
the researchers wrote in their study. Similar Study in the US In the UK, pre-eclampsia affects about one in 20 pregnancies
or 80,000 women each year, New
Scientist explained. While in the US, data compiled from the Centers for Disease Control
and Prevention (CDC) indicate that pre-eclampsia affects one in 25
pregnancies or about 154,220 women annually. Researchers in Ohio also recently reported on a test and a piloted
clinical study for rapid diagnosis of pre-eclampsia. Scientists at Ohio State University’s College of Medicine and Wexner Medical Center (OSU), and at Nationwide Children’s Hospital,
have developed a non-invasive red-dye-on-paper urine test to identify
pre-eclampsia at the point-of-care, a Wexner press
release announced. “This is the first clinical study using the point-of-care,
paper-based Congo Red Dot (CRD) diagnostic test, and the mechanism proved
superior in establishing or ruling out a diagnosis of pre-eclampsia,” Kara Rood, MD, a maternal-fetal
medicine physician at Wexner Medical Center and first author of the study said
in the Wexner press release. “Our findings will have a huge impact on the
health of women and children.” The researchers published their findings in EClinicalMedicine,
a Lancet Journal. “Pre-eclampsia is often described as ‘mysterious’ because
it’s difficult to diagnose. Our researchers show that there’s an easy,
non-invasive test that will help diagnose this condition and maintain the
health of pregnant women and their babies,” K. Craig
Kent, MD, OSU Dean of the College of Medicine, said in the press release. Clinical laboratory tests such as these being developed in
the US and abroad could help pregnant women worldwide experience happy
pregnancies and give birth to healthy babies. Medical laboratory leaders in
this country may want to stay abreast of the development of these simple blood
and urine tests. —Donna
Marie Pocius Related Information: Pre-Eclampsia: NHS to Roll Out Breakthrough Test Which Speeds Up Diagnosis and Can Save Lives Blood Test Helps Accurate, Rapid Diagnosis for Pre-eclampsia Pre-Eclampsia Blood Test Could Help Diagnose the Condition Earlier Research Finds Simple Urine Test Allows for Rapid Diagnosis of Pre-eclampsia