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Maternal Health

Will the FDA-Approved Blood Test for Preeclampsia Decrease Maternal Deaths?

“Are we really getting to the crux of the issue?” Doctors and midwives weigh in on how effective the test might be.

The Food and Drug Administration recently approved a blood test that can be a tool in predicting which patients are at higher risk of developing severe preeclampsia — a condition Black women are much more likely than white women to battle and face worse consequences. (Getty Images)

The recently approved test that can predict which pregnant patients are at risk for developing severe preeclampsia is a promising step, Black doctors and midwives say, but there are limitations. 

“It’s definitely a welcomed tool, so we are hopeful,” said Dr. Garfield Clunie, president of the National Medical Association, which represents Black doctors. “The pause I have is that as a physician, you have to treat the whole patient. You can’t treat to a lab result. This may help, but it’s not a cure all.”

The Food and Drug Administration’s approval of the blood test offered a glimpse of hope earlier this month, but the reality of how the test can be used, what it was approved for by the FDA, and how effective it might be at protecting patients before complications arise limits its reach.

The health care community’s cautious optimism is dimmed largely by the startling severity of the maternal mortality crisis, one that places outcomes in the U.S. as the worst among developed nations, driven in part by high rates of preeclampsia.

The condition is characterized by dangerously high blood pressure, which can trickle into life-threatening organ failure and seizures. Its rates have increased rapidly across the country over the past decade, and Black women are much more likely than white women to battle the condition and face the worst consequences.

“Preeclampsia is a killer,” said Jennie Joseph, a British-trained midwife who runs a birth center in Winter Garden, Florida. “White women aren’t dying in the same way that Black women are.”

The number of Black women who have battled the condition continues to rise, as wealth, fame, and socioeconomic status prove not to be protective factors for them. Beyoncé. Allyson Felix. And, more recently, the death of U.S. Olympian Tori Bowie, has spotlighted the crisis. 

While promising, the test does not eradicate or address the racism and sexism that seeps into the American health care system, leaving Black families vulnerable. 

“Are we really getting to the crux of the issue?” wonders Dr. Rachel Bervell, co-founder of The Black ObGyn Project. “Really, what we’re dealing with is bias.”

Maybe, she said, the blood test offers an added layer of protection. If clinicians do not believe Black patients when they complain about common preeclampsia symptoms like headaches and swelling, said Bervell, this test can add another data point to the already existing tools that alert physicians to severe complications. 

Read More: Clinicians Dismiss Black Women’s Pain. The Consequences Are Dire.

She wonders if the test will give physicians more confidence in identifying when serious illness is brewing and help patients be heard. Among Black moms who have died or nearly died in childbirth, those who live to tell the story often reveal feeling dismissed by doctors. According to a report published last year, more than 70% of Black women ages 18 to 49 said they’ve experienced at least one negative interaction with care providers, including dismissal of their pain.

“Now we have another layer where you cannot deny something is going on,” Bervell said. But, “how many more layers do you need to show that we need to react?”

Read More: Haunted By Trauma: The Black Parents Who Nearly Died In Childbirth

How does the test work?

The test is not designed to be administered to low risk patients, or outside of the hospital. It is approved for use among pregnant women who have already been admitted to emergency facilities in the 23rd to 35th weeks of gestation for high blood pressure to determine their risk for increasingly severe complications within the next two weeks. Those who test positive — based on the ratio of different proteins in their blood at the time — would need more surveillance and specialized care to prevent the condition from escalating. Others can be safely discharged.

“It is not a routine blood test,” said Dr. Sarah Kilpatrick, an OBGYN at Cedars-Sinai in Los Angeles who studied the test. “It’s to help separate out those who are likely to get sick from those who are not.”

Because the test is so accurate, she said, it’s reassuring to both the patient and doctor that they are taking the right steps and not missing symptoms. Sometimes patients can have high blood pressure readings and not develop preeclampsia, Kilpatrick said. It can be hard to tell, and the test offers more clarity. 

The study she led had about 1,000 patients and a diverse sample that is representative of the U.S. population, including 31% Black women and 16% Hispanic women. And, it was funded — at least in part — by Thermo Fisher Scientific, the biotechnology company that developed the blood test.

Although about half of maternal deaths occur after delivery or during the postpartum period, the test is not intended for use then. It is unlikely the test would work after birth, Kilpatrick said. 

Although its application is a limited one, it’s important, experts say. It’s valuable in terms of preventing death within the hospital, said Dr. Amanda P. Williams, a California-based OB-GYN. 

“The issue primarily is what is happening outside of the hospital, and this test does not address that piece of the puzzle,” she said. But it could reduce the financial burden of long hospital stays, given its accuracy in predicting which patients will not develop severe complications. 

Who will have access?

It has been available in Europe for a number of years already. Exactly how this test will roll out across the U.S. remains uncertain.

“We are actively engaged with customers now, and so it shouldn’t be long before patients in the U.S. are being tested,” said a spokesperson with Thermo Fisher Scientific in response to a request from Capital B. The company did not share how much the test would cost. “The pricing varies depending on a number of factors,” the response says. “However, we are focused on making them as widely available as possible.”

The cost could affect which communities get access to the potentially life-saving assessment. If it is expensive, experts wonder if it will reach the most vulnerable populations. And if it does, they want to be sure it’s safe and effective. 

“We don’t know how different hospitals will go about that assessment, and whether they want to be making it available to patients,” Williams said. She always has a guarded optimism when such tests are developed, she said. 

Another question, among many others, is how insurance companies will adapt. 

Some are skeptical about whether the latest technology will safeguard against severe complications. So much time, energy, and money is spent on developing instant, miracle cures rather than listening to patients, said Joseph, the midwife, who was also recognized as one of Time magazine’s Women of the Year last year. “It’s the way [doctors] behave that’s killing us.”

The racism and sexism baked into the health care system, and how clinicians respond to it by ignoring patients or not treating them well, is, in large part, driving the death rates, Joseph said.  

Still, some are a bit more optimistic. 

“Any way we can move the needle to help identify [high-risk] individuals earlier, to help get them closer to treatment, to help get them closer to management or in some cases deliver when something is going really badly or when something is severe, is promising,” Bervell said.