A new, simple test can now quickly detect preeclampsia, a pregnancy condition that can be harmful to mothers and children.
The condition occurs when a woman has high blood pressure and one or more of the following problems after the 20th week of pregnancy: protein in urine, low platelets, impaired liver function, fluid in the lungs, signs of kidney trouble, and other symptoms, according to the Mayo Clinic.
Several tests can diagnose preeclampsia, including blood and urine samples, as well as fetal ultrasounds. However, the condition can be tough to identify, especially in women with other complications.
In response, researchers from The Ohio State University (OSU) Wexner Medical Center and Nationwide Children's Hospital designed a rapid urine test to better diagnose preeclampsia. It uses an affordable and non-invasive clinical "red dye-on paper" process known as the Congo Red Dot (CRD) test.
“Our simple test allows us to tell the difference between preeclampsia and other chronic diseases that are clinically indistinguishable from preeclampsia,” Dr. Kara Rood, author of the paper and a fellow in the division of maternal-fetal medicine in the department of obstetrics and gynecology at the OSU Wexner Medical Center, told Healthline.
Preeclampsia affects 5 to 8 percent of pregnancies across the globe. It’s the culprit behind 18 percent of maternal deaths in the United States and 13 percent worldwide.
Preeclampsia can lead to eclampsia, a condition that sometimes requires doctors to induce labor in pregnant women and deliver infants before their due date. Premature birth increases the risk of learning disabilities, cerebral palsy, and blindness in newborns.
The Science Behind the Test
For their study, researchers enlisted 346 pregnant women who were set to be assessed at the OSU Wexner Medical Center for preeclampsia. They tested their urine using the CRD test as well as the additional biochemical tests for preeclampsia.
In all, 89 of the pregnant women had a clinical diagnosis of preeclampsia and 79 percent of the group had a medically indicated preterm birth for preeclampsia, delivering at an average of 33 weeks.
The CRD test was superior to the other biochemical tests with an accuracy rate of 86 percent. It can spot preeclampsia before clinical symptoms appear, researchers said.
“This is the first clinical study using the point-of-care, paper-based CRD diagnostic test, and the mechanism proved superior in establishing or ruling out a diagnosis of preeclampsia. Our findings will have a huge impact on the health of women and children,” Rood said in a statement.
She presented the results at the Society of Maternal-Fetal Medicine's annual pregnancy meeting in Atlanta.
Test Created Inadvertently
Rood didn’t invent the test.
Dr. Irina A. Buhimschi, director of the Center for Perinatal Research in The Research Institute at Nationwide Children's, first discovered it with colleagues.
In studying the urine of pregnant women, they were able to characterize misfolded proteins that may cause the condition, which led to the creation of the CRD test. Preliminary results published in the July 2014 issue of Science Translational Medicine showed an 89 percent accuracy rate.
Buhimschi said that the new test is a more user-friendly version of her original trial.
Both research teams are also examining how the misfolded proteins can affect pregnant women. They hope more research can lead to treatment and prevention developments.
Rood told Healthline that GestVision is the commercial partner that will develop and produce the test kits. They will have to undergo more testing to meet U.S. Food and Drug Administration requirements. It will be a year or more before kits could be available to patients.