Preeclampsia, or the rapid onset of high blood pressure in pregnancy, is one of the leading causes of maternal death—and it’s common. Happening in about 1 in 25 pregnancies in the US, according to the Centers for Disease Control and Prevention (CDC), the condition can often appear without symptoms, making it difficult to predict or detect—until it happens. But the Food and Drug Administration (FDA) recently approved a blood test which may serve as an early warning for preeclampsia, indicating that women who test positive may continue to have the condition for two weeks.
The test from Thermo Fisher Scientific is designed to detect a certain imbalance of the two placental proteins which can be used to predict whether a pregnant woman may be at risk of developing a severe form of the condition. The test has been available in Europe for several years, The New York Times reports.
“Doctors can use this in conjunction with other clinically available tests to group their patients together to determine whether they are at high risk for severe preeclampsia and complications, or at low risk, to be managed appropriately,” said Sarosh Rana, MD, MPH, chief of maternal-fetal medicine at the University of Chicago Medicine, and a lead author of the study submitted to the FDA for approval, in a statement.
Preeclampsia can occur after the 20th week of pregnancy and can occur even up to 6 weeks postpartum, and can be serious or life-threatening for a mother and the developing baby, straining maternal organs and affecting blood flow to the placenta. Authorities suspect the condition may have led to the recent death of Olympian Tori Bowie, who was 8 months pregnant. The condition disproportionately affects Black women, likely due to racism and systemic inequality that increase the risk of illness.
Every year, preeclampsia is responsible for more than 70,000 maternal deaths and 500,000 fetal deaths worldwide, the FDA says. Until now, there is a lack of clinical tools available to diagnose this condition since its occurrence first recognized in 1900.
The symptoms of preeclampsia can be mistaken for normal pregnancy symptoms
Hallmark symptoms, when they appear, include persistent headaches, swelling, high blood pressure, vision changes and signs of liver and kidney damage, such as protein in the urine, nausea or vomiting, and increased liver enzymes. Some, such as headaches, swelling and nausea, are common in pregnancy. But having preeclampsia in pregnancy can lead to long-term conditions later in life.
“Women with preeclampsia are at increased risk for short-term and long-term hypertensive disorders and cardiovascular disease for the rest of their lives.”
At 28 weeks, Jodi Klaristenfeld’s “seemingly ‘perfect pregnancy'” took a big turn. “I gained twenty pounds in five days, my urine turned orange, I started seeing spots, and my vision got blurry,” she told Motherly. “I later learned that I had a life-threatening condition called HELLP syndrome—a rare form of preeclampsia that eventually led to my daughter’s preterm birth.”
Klaristenfeld was induced a few hours after arriving at the hospital, and during labor, her blood pressure rose to 190/150. Doctors gave him a platelet transfusion. “If it wasn’t for my mother’s encouragement to seek medical help, I’m not sure where I would be today. Thankfully, my daughter Jenna was born and, four years later, she is a happy and thriving little girl.
Now an advocate for NICU parents and the founder of FLRRiSHKlaristenfled is committed to spreading awareness about preeclampsia and preterm birth to help educate and empower families.
Identifying the need for increased surveillance
Outside of using drugs to lower blood pressure, the only current treatment for preeclampsia is delivery. But the new test could help identify who might need increased care or monitoring or an induction to deliver early. If left untreated, preeclampsia can progress to eclampsia, which can result in seizures and a medical emergency.
In those who get a negative test result, the blood test is 96% accurate that a patient will not develop preeclampsia in the next two weeks. Of those who get a positive test result, about 66% of those patients are expected to develop severe preeclampsia within two weeks and may require increased monitoring and possible early delivery.
Experts and advocates celebrated the test’s approval. “Patients and providers would benefit from having better tests to predict progression to preeclampsia with severe features, especially for patients at risk of severe, early-onset disease or where there is some diagnostic uncertainty,” said Eleni Tsigas, CEO at the Preeclampsia Foundation, in a statement. “Our organization celebrates this result after years of advocacy with research leaders and regulatory bodies, such as the FDA, to accelerate the development and adoption of better clinical tools.”
For decades, preeclampsia was not fully understood, but now, researchers are making progress. Scientists at the University of Virginia recently identified a specific “lipid signature” in women who develop preeclampsia it can also be used as a biomarker tool to detect the condition before it becomes severe. The researchers at Comanche Biopharmaled by Chief Medical Officer Allison August, MD, who worked on the Phase 3 clinical trial for Moderna’s mRNA Covid vaccine, is also developing a novel siRNA therapy for the treatment of preeclampsia.
