This could have a major impact on the health of pregnant women worldwide. In an effort to reduce illness and deaths among expecting mothers and their unborn children, maternal-fetal medicine and perinatal physician-researchers designed a rapid tool to identify preeclampsia using an affordable and non-invasive clinical “red dye-on paper” test.
It was piloted in a clinical study at Ohio State Wexner Medical Center. The results are published in Lancet’s E-Clinical Medicine.
“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 preeclampsia,” said Dr. Kara Rood, first author on the collaborative project and maternal-fetal medicine physician at Ohio State Wexner Medical Center. “Our findings will have a huge impact on the health of women and children.”
About one in 20 women develop preeclampsia during pregnancy, which can be life-threatening to both moms and babies. However, it is difficult to diagnose because symptoms often mimic those of a normal pregnancy, such as swelling and headaches.
Managing the condition early is critical to keeping mother and child safe, and now a new innovation may help start treatment sooner by quickly identifying preeclampsia with a simple urine test. In a new study, researchers at The Ohio State University Wexner Medical Center tested a fast and easy test to accurately diagnose the condition in just three minutes.
“Giving birth is the only cure for preeclampsia, but it can develop as early as the second trimester,” said Dr. Kara Rood, lead author of the study and maternal-fetal medicine physician at Ohio State Wexner Medical Center. “The quicker we identify women with the condition, the better chance they have of carrying their babies to full term and having a healthy delivery.”
Currently, preeclampsia is identified by high blood pressure and elevated proteins in the urine. The disorder is the number one reason physicians decide to deliver children prematurely and is responsible for approximately 18 percent of maternal deaths in the U.S. “Preeclampsia affects up to eight percent of pregnancies. The challenge is that it’s a progressive disease and not everyone progresses at the same time,” said Rood, who is also an assistant professor of maternal-fetal medicine at The Ohio State University College of Medicine. “Some women can have the disease for weeks before having symptoms, whereas other women can progress to a dangerous level within days.”
The test uses a special red dye that reacts to unique proteins in the urine of pregnant women with preeclampsia. It can be given easily during a prenatal visit, providing an immediate diagnosis. “Without the certainty of this test, providers tend to be overcautious because this is definitely a condition that we can’t allow to go untreated,” said Rood. “This test helps us to quickly provide care to women with preeclampsia, while avoiding unnecessary admissions or even early deliveries.”
In the study, researchers enrolled 346 pregnant women who were being evaluated for high blood pressure and possible preeclampsia. They used the CRD urine test which provides results at the bedside within three minutes. Trained clinical research nurses analyzed results before the patient’s doctor made a final diagnosis. Results of the CRD test were not shared with the patient’s care team.
Eighty-nine of the pregnant women had a clinical diagnosis of preeclampsia. Of those, 79 percent were induced due to preeclampsia, with an average age of delivery at 33 weeks gestation. The team found the CRD test was superior to the other biochemical tests, with an accuracy rate of 86 percent.
These findings confirm that the CRD test is a simple, “sample in/answer out” clinical tool that allows for very accurate and rapid diagnosis of preeclampsia, Rood said. “Preeclampsia is often described as “mysterious” because it’s difficult to diagnose,” said Dr. K. Craig Kent, dean of the College of Medicine. “I’m proud of our dedicated researchers for showing that there’s an easy, non-invasive test that will help diagnose this condition and maintain the health of pregnant women and their babies.”
If undetected, preeclampsia can lead to eclampsia, one of the top five causes of maternal and infant illness – including seizures and coma – and the cause of 13 percent of maternal deaths globally. Pregnant women may be induced and unborn children delivered early, even if there’s just suspicion of preeclampsia. Premature birth is also a concern because it increases the risk of learning disabilities, cerebral palsy and blindness in newborns.
Researchers expect the new rapid test to be FDA approved in the next few years so that OB/GYNs nationwide can use it to identify cases of preeclampsia. Dr. Rood hopes it will also be available for women to use at home to monitor complications during pregnancy.