Around the world, far too many women and babies are suffering the sometimes fatal consequences of preeclampsia. This dangerous pregnancy complication—characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys—can happen to anyone, but it disproportionately affects Black mothers and women over 35.
Despite advances in healthcare, women in the U.S. are still dying and being hospitalized at higher rates than in other developed countries, with preeclampsia and related hypertensive disorders of pregnancy impacting between 5% and 8% of all U.S. births each year. Notably, preeclampsia has increased 25% in the last two decades in the U.S. and is a leading cause of maternal and infant illness and death, according to data from the Preeclampsia Foundation.
The impact of preeclampsia on mothers and babies can be devastating, and researched published in the journal Obstetrics & Gynecology in 2015 shows many deaths and much of the trauma caused by preeclampsia and preterm birth can be prevented by reading and responding to warning signs that are too often overlooked. For instance, the Mayo Clinic acknowledges that certain symptoms—such as high blood pressure, swollen feet, ankles and hands, or headaches—can be misdiagnosed or mistaken for the normal effects of pregnancy, making them easy to brush off and preeclampsia difficult to diagnose. Furthermore, if preeclampsia goes undiagnosed, the condition can increase in severity very quickly, as noted by the physician author of this Ochsner Health blog.
There is a clear need for a more innovative solution.
When it comes to preeclampsia, knowing can spare lives. However, with no FDA approved tests for ruling out preeclampsia in the U.S., clinicians currently rely on basic methods for diagnosis in expectant mothers, such as monitoring blood pressure after 20 weeks and measuring protein in the urine, which are poor predictors of who will develop adverse outcomes and who will go on to have normal pregnancies. As a result, women may be hospitalized out of precaution, even though many who present with signs of preeclampsia won't develop the condition, according to a 2016 PLoS ONE study. The lack of available tools to rule out preeclampsia is causing additional stress and worry for patients and providers, while also straining our hospitals and healthcare system with the burden of unnecessary hospitalization.
Biomarker testing provides new options for clinicians and patients.
Using a blood sample, biomarker tests can drastically improve the decision-making process for clinicians with patients who present with signs and symptoms of preeclampsia. The biomarker test that evaluates Elecsys® sFlt-1/PlGF ratio, while not yet available in the U.S. and Japan, is currently used by some physicians in all countries accepting the European Conformity mark in Europe, Latin America, Middle East, Africa and Asia. Physicians using this biomarker ratio can send healthy women home with more confidence and focus patient management on those who are more likely to need it.
When a clinician can’t rule out preeclampsia, there is a temptation to be cautious and deliver the baby; after all, the lives of a mother and baby are at stake. However, delivery is not a risk-free path either, as doing so too early presents a risk for the mother and baby. Having a successful rule-out strategy can empower clinicians with the confidence to stay the course.
Advanced diagnostics technology can improve outcomes, while reducing costs.
Research published in the American Journal of Obstetrics & Gynecology found that in 2012 alone, preeclampsia cost the U.S. an additional $2.18 billion above the usual maternal and infant costs associated with birth. Using biomarker testing as an aid to rule out preeclampsia could help reduce the associated healthcare costs by cutting inappropriate discharges and unnecessary hospitalizations, as well as reducing births of low gestational age.
As a maternal fetal health physician, I am excited by the potential of biomarker testing to set a new standard for prenatal care in the U.S. and help prevent unnecessary pain and suffering for mothers and babies. At Roche Diagnostics, we have long been dedicated to addressing women’s health needs, developing a portfolio of innovative testing solutions to help ensure a healthier life, and we are committed to helping to change the status quo in preeclampsia.
Liza Kunz, MD, FACOG, is the obstetrics and gynecology disease area network lead for Roche Diagnostics.