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Approval of Preeclampsia Blood Test: A Step Forward, But Miles Still to Go

Jay S. Lupin, Obstetrics & Gynecology

July 20, 2023

Approval of Preeclampsia Blood Test: A Step Forward, But Miles Still to Go

Headlines were made earlier this month when the Food and Drug Administration approved a blood test that can identify pregnant women who are at elevated risk of developing preeclampsia, a leading cause of death among childbearing women. But while the FDA’s approval is certainly good news, it may represent a mere baby step in learning more about the disorder.

Preeclampsia is a significant complication of pregnancy, manifested by an increase in blood pressure (>140/90), and associated with the spillage of protein in the urine. It typically starts after the 20th week of pregnancy, or even after giving birth. The American Heart Association estimates that the disorder affects as many as one in 25 pregnancies in the U.S. In addition to high blood pressure (which may continue even after giving birth), preeclampsia can also cause damage to the kidneys, liver, lung, heart, and/or eyes depending on the severity of the disorder.

A related condition, eclampsia, refers to the occurrence of seizures in patients with preeclampsia. Either condition can affect not just the person giving birth, but the baby as well.

Many of the early signs of preeclampsia mirror those of other ante-partum symptoms: headaches, nausea, and various aches and pains. However, if such headaches and/or stomach aches are severe, vision is blurred, and/or extreme shortness of breath is present, you should seek professional medical help.

It has been found that women having their first pregnancy, aged 40 and older, or younger than 18, and/or who have had preeclampsia during earlier pregnancies, are at a higher risk of developing preeclampsia. Being pregnant with more than one fetus can also play a part, as does a history or obesity and gestational diabetes. There is evidence that women of African-American ethnicity are also more prone to the disorder.

With all this uncertainty, what can be done to avoid developing preeclampsia? Patients at risk should start a baby aspirin every day starting in the second trimester and continuing until birth; studies have found doing this can decrease your risk by about 15%. Additionally, regular monitoring of one’s blood pressure is essential to identify changes as early as possible.

What the Approved Test Does

The FDA-approved blood test, developed by Thermo Fisher Scientific, measures the ratio of two proteins that are produced by the placenta. The Massachusetts firm found that the two proteins were significantly unbalanced in the blood of women who will develop preeclampsia with severe features within the next two weeks from testing. The test is predictive of a 65% chance of progressing to preeclampsia with severe features. The likelihood of progression is significantly decreased if the ratio is within a lower range.

As was the case before the FDA’s approval of this test, preeclampsia is a progressive disease process, and the only “cure” for such women is delivery, which can pose its own risks.

The Thermo Fisher test is certainly worthy of note. We should all view it as a welcome advance – and hope for more such gains against preeclampsia in the future.

Jay S. Lupin

Dr. Jay S. Lupin is Director, Obstetrics & Gynecology at White Plains Hospital.