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CLEVELAND, Ohio — Until now, watch and wait was about the best advice many OB/GYNs could give pregnant patients at risk for preeclampsia and its sometimes-fatal complications for moms and babies.
Now a new test, recently approved by the U.S. Food and Drug Administration, can predict imminent preeclampsia, by looking for biomarkers in the blood.
The breakthrough test — the first one specific to preeclampsia — identifies which women will not develop the disorder within two weeks with nearly 96% accuracy.
Preeclampsia, a leading cause of maternal deaths, disproportionally affects African-American women. The rate of preeclampsia in Black women is 60% higher than in white women, and African-American women are also more likely to experience worse health associated with the condition, according to the U.S. Centers for Disease Control and Prevention.
Some experts in women’s health think the biomarker test could help decrease the high maternal death rate in the United States.
But some health systems, including those at the Cleveland Clinic and University Hospitals, are awaiting more information before beginning to offer the test to their patients.
“Hopefully we can tell patients, ‘You have a high risk (for preeclampsia). You don’t have a high risk,’ ” said Dr. Oluyemi Aderibigbe, maternal fetal medicine at the Cleveland Clinic. “If you can make that distinction, it will help them, so I am excited about this breakthrough.”
The Clinic, however, as a policy is not implementing the test at this point.
“While the FDA has approved this test, no professional societies (American Congress of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine) has weighed in on integration of this test into clinical practice, our OB/GYNs and maternal fetal medicine physicians follow American Congress of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine guidance,” the Clinic said in a statement.
The American College of Obstetricians and Gynecologists is reviewing data for the new biomarker blood test, said Dr. Christopher M. Zahn, interim chief executive officer and chief of clinical practice and health equity and quality for the American Congress of Obstetricians and Gynecologists.
UH is following the development as a possible future care option.
There isn’t scientific evidence yet that changing care for patients who test positive will improve their outcome, said Dr. Christopher Nau, OB/GYN and maternal fetal medicine at UH. These patients are already having their blood pressure checked several times a day, getting weekly lab tests and undergoing twice weekly fetal testing.
“The maternal fetal medicine team at UH expects (and hopes) that in the near future the science will progress to the point that this test or similar ones will end up becoming commonplace in the diagnosis and management of preeclampsia,” Nau said.
Multiple U.S. medical centers will have the test available to patients in October, and hundreds of hospitals will have access to the test by the end of the year, said Thermo Fisher Scientific, the test’s creator.
Preeclampsia, a complication of pregnancy, causes high blood pressure and can damage multiple organs. The disorder can result in preterm births, small-sized babies and NICU admissions.
Dr. Sarosh Rana, who has studied the test as section chief for maternal-fetal medicine at the University of Chicago Medicine, said the biomarker blood test showed some of her patients were at low risk of preeclampsia, and they might not need to deliver early as previously may have been the case.
“Those patients went quite far in their pregnancy, so they were very, very happy,” Rana said.
Preeclampsia occurs in up to 7% of all pregnancies and is one of the leading causes of maternal death, according to the CDC. Worldwide, preeclampsia is responsible for more than 70,000 maternal deaths and 500,000 fetal deaths.
In Ohio, preeclampsia and eclampsia — convulsions occurring in a pregnant woman with preeclampsia — accounted for 12% of pregnancy related deaths between 2008 and 2016, with a disproportionate number of deaths among non-Hispanic Black women, compared to the overall population, according to state data.
The risks that preeclampsia poses to Black women was brought into sharp focus with the death this year of American track and field champion Tori Bowie. She died of pregnancy complications that may have included eclampsia.
Other famous moms who have faced preeclampsia complications include singer Mariah Carey and star of the “Vanderpump Rules” television show Scheana Shay, according to news reports.
Hospitals need special equipment for test
The new blood test, available in Europe, measures the ratio of two proteins produced by the placenta that indicate placental health. Researchers found those proteins were highly unbalanced in women who later developed severe preeclampsia.
In trials, the biomarker blood test was found to be more accurate than other ways to detect preeclampsia, such as ultrasounds and blood pressure checks, Rana said.
The blood test is meant for women in the 23rd to 35th weeks of pregnancy.
The test will only be given to women who are already hospitalized for high blood pressure. Women who test positive for the likelihood of developing preeclampsia can be transferred to a medical facility that specializes in caring for high-risk pregnancies, Rana said.
For those who test negative, “I’m going to reassure the patient that I know you’re admitted with high blood pressure, but your risk to develop severe preeclampsia in the next two weeks is rather low,” Rana said. “I’m just going to follow you very, very carefully. The risk is not zero, but it’s extremely low.”
The test is designed to run on the Thermo Scientific clinical chemistry analyzer that can deliver results in less than 30 minutes, according to the company. The company declined to state how much the analyzer costs.
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The preeclampsia blood test has to be used in conjunction with other tests currently being used to monitor pregnancies, Rana said.
“We are not proposing using these tests to decide whether the patient can go home or she needs to continue admission,” Rana said. “Those decisions are complicated. We are saying that this test should be used along with other lab tests and clinical assessment.”
First-time moms at risk for preeclampsia
Preeclampsia happens when a woman who previously had normal blood pressure suddenly develops high blood pressure and protein in her urine. The disorder usually begins after 20 weeks of pregnancy.
Pregnant women with chronic hypertension can also get preeclampsia.
In rare cases, preeclampsia can happen after giving birth, a condition known as postpartum preeclampsia.
Those at risk for preeclampsia include women giving birth for the first time or had preeclampsia previously, have long-term high blood pressure or kidney disease; pregnant with twins or triplets, or have a family history of preeclampsia, according to the CDC.
Other high-risk factors include having diabetes, obesity or lupus, or being over age 40.
Symptoms include a persistent headache, nausea, swelling of face or hands, changes in vision, stomach pain and trouble breathing.
Physicians often recommend delivering a baby early to deal with preeclampsia. Before delivery, pregnant women with the illness are given medications that lower blood pressure.
“Preeclampsia is a dangerous disease in pregnancy and the solution is always delivery of the baby,” the Clinic’s Aderibigbe said. “Once you have preeclampsia, we have to manage the risk to the mom and the baby and determine when we deliver the baby.”
Julie Washington covers healthcare for cleveland.com. Read previous stories at this link.
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