Research at the Wexner Medical Center and Nationwide Children’s Hospital is expanding the world of women’s health with a clinical study conducted at the medical center showing promising results for the Congo Red Dot test in quickly diagnosing preeclampsia, a condition that affects pregnant women.
Preeclampsia is characterized by raised blood pressure and damage to organ systems, particularly kidneys, according to the Mayo Clinic website.
If preeclampsia is undetected, it can lead to eclampsia — an illness that is responsible for 13 percent of maternal deaths worldwide, according to a Wexner Medical Center press release. Because of the danger that eclampsia poses to both mother and child, women who are just suspected to have preeclampsia might be induced and have to undergo childbirth early, which comes with its own set of risks.
The CRD test could decrease the number of unnecessary premature births by taking the guessing aspect out of diagnosing preeclampsia.
The next step for the CRD test will be clinical trials in low-income countries, specifically Mexico, Bangladesh and South Africa. Dr. Kara Rood, a fellow in the Division of Maternal-fetal Medicine at the Wexner Medical Center, said this process is projected to begin in May.
The CRD test had an accuracy rate of 86 percent, making it superior to the other biochemical tests used to diagnose preeclampsia in the study, she said.
Still, there’s a long road ahead before it will gain approval from the Food and Drug Administration and can be used by physicians, said Dr. Irina Buhimschi, director of the Center for Perinatal Research at Nationwide Children’s Hospital, who conceived the idea for the CRD test.
“There are many pieces that need to come together for this to come to life,” Buhimschi said.
Buhimschi began developing the test more than seven years ago, seeking to create the first point-of-care test that could accurately diagnose preeclampsia.
“We need a simple test that tells you the answer right there and then,” Buhimschi said.
The clinical study that took place at the Wexner Medical Center spanned from July 2014 to July 2015 and involved 346 pregnant women who were being evaluated for preeclampsia.
Rood became involved in the process of developing the CRD test more than two years ago. She discussed the impact that the noninvasive test could have.
“(The CRD test) would be able to minimize admissions to the hospital as well as triage evaluations because those evaluations could be performed in a physician’s office or in routine prenatal care,” Rood said.
When the CRD test does come to life, the impact it could have on women’s health could be seen worldwide.
“As a physician, the impact you have in your lifetime is on 100, 200, 2,000 people,” Buhimschi said. “But as a researcher, and especially when you do research in low-income countries, you can impact the entire population of the country.”