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• Posted July 5, 2023

FDA Approves First Blood Test to Predict Preeclampsia in Pregnant Women

A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk of this severe and sometimes deadly form of high blood pressure.

The test can identify with 96% accuracy which women with sometimes-vague symptoms will develop preeclampsia within the following two weeks, The New York Times reported this week.

"It's groundbreaking. It's revolutionary,"Dr. Douglas Woelkers, a professor of maternal-fetal medicine at the University of California, San Diego, said of the test.

"It's the first step forward in preeclampsia diagnostics since 1900, when the condition was first defined,"Woelkers added in the news report.

The blood test was created by Thermo Fisher Scientific. It is meant for women in the 23rd to 35th weeks of pregnancy.

Those who don't test positive can be safely discharged from the hospital, while two-thirds of those with a positive result will advance to severe preeclampsia.

Women who are positive may need to deliver their babies early.

"We don't have a therapy that reverses or cures preeclampsia other than delivery of the baby, which is more like a last resort,"Woelkers said in the news report.

Black women are particularly at risk of preeclampsia, with much higher rates than white women. They are also more likely to experience kidney damage, death and to lose their babies, the Times reported. Overall, the condition affects one in 25 pregnancies.

Preeclampsia may have contributed to the recent death of Olympic track star Tori Bowie. Allyson Felix and Tianna Bartoletta, Black women who were Bowie's teammates, also were diagnosed with preeclampsia while pregnant.

Preeclampsia typically begins about midway during a pregnancy, but can also happen after childbirth. It can lead to eclampsia, with severe symptoms including seizures and death.

"The warning signs of preeclampsia are not very specific,"said Dr. Sarosh Rana, a professor of obstetrics and gynecology at the University of Chicago, who has studied the test. "A lot of women will have edema (swelling) and headaches."

"But we don't really know who among those patients is at higher risk for the really adverse outcomes,"Rana said.

Women with symptoms may need to have a repeat blood test every two weeks, according to the news report.

The test, which is already available in Europe, works by measuring the ratio of two proteins produced by the placenta. A study found those proteins were highly unbalanced in women who later developed severe preeclampsia.

In that study, researchers tracked more than 1,000 pregnant women who were hospitalized at 18 medical centers between 2019 and 2021 with high blood pressure. The findings were published in NEJM Evidence.

More information

The March of Dimes has more on preeclampsia.

SOURCE: The New York Times