New field-based test for preeclampsia validated in large-scale study.
Preeclampsia, which affects 5 to 8% of pregnancies worldwide, is characterized by high blood pressure and protein in the urine. The disorder is the number one reason physicians decide to deliver children prematurely and is responsible for approximately 18% of maternal deaths in the U.S. Experts describe preeclampsia as extremely difficult to diagnose. Now, researchers from The Ohio State University and Nationwide Children’s Hospital state that they have developed a simple test which can rapidly detect one of the world’s most deadly pregnancy-related conditions. The team state that their findings will have a huge impact on the health of women and children. The study was presented at the Society of Maternal-Fetal Medicine’s annual pregnancy meeting.
Previous studies show that if undetected, preeclampsia can lead to eclampsia, the cause of 13% of maternal deaths globally. However, the cause of preeclampsia is still unclear. Possible causes include injury to the mother’s blood vessels, or a disruption in the hormones that maintain her blood vessels. Eclampsia usually develops when preeclampsia goes unnoticed and untreated. Earlier studies from the group showed that preeclampsia may result from a collection of improperly folded proteins similar to those associated with Alzheimer’s disease. They studied the urine of pregnant women with preeclampsia and were the first to characterize the range of misfolded proteins, with preliminary results showing an 89% accuracy rate. The current study designs a rapid tool based on detecting these proteins to identify preeclampsia using the affordable and non-invasive clinical ‘red dye-on paper’ test.
The current study enrolled 346 pregnant women who were being evaluated in the labour and delivery triage unit at OSU Wexner Medical Center for preeclampsia, using the Congo Red Dot (CRD) urine test. Trained clinical nurses analyzed results at the patient’s bedside before a final diagnosis was made, with the team unaware of the results; additional biochemical tests for preeclampsia were also performed on the urine. The lab state that, to their knowledge, their study is the first to use the point-of-care, paper-based CRD diagnostic test.
Data findings show that eighty-nine of the pregnant women had a clinical diagnosis of preeclampsia, and 79% of these women had a medically-indicated preterm birth for preeclampsia, with an average age of delivery at 33 weeks gestation. Results show that the CRD test was superior to the other biochemical tests, with an accuracy rate of 86%.
The team surmise that their findings confirm that the CRD test is a simple clinical tool which allows for very accurate and rapid diagnosis of preeclampsia. They go on to add that this new point-of-care test is user-friendly and can help identify preeclampsia even before clinical symptoms appear. For the future, the researchers state that they are now investigating how each misfolded protein collection affects pregnant women, with view to developing an effective treatment or even preventing preeclampsia.