FDA Approves Blood Test for Preeclampsia in Pregnant Women.

FDA Approves Blood Test for Preeclampsia in Pregnant Women.

A Revolutionary Test to Predict Preeclampsia

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A new blood test has been approved by the U.S. Food and Drug Administration (FDA) that can predict the onset of preeclampsia, a severe and sometimes deadly form of high blood pressure in pregnant women. With an accuracy rate of 96%, the test can identify women who are at risk of developing preeclampsia within the following two weeks[^1^]. This breakthrough was hailed by experts as groundbreaking and revolutionary, marking a significant advancement in preeclampsia diagnostics since it was first defined in 1900[^1^].

What is Preeclampsia?

Preeclampsia is a condition that affects pregnant women and is characterized by high blood pressure and damage to organs such as the liver and kidneys. It typically occurs during the second half of pregnancy but can also develop after childbirth[^1^]. If left untreated, preeclampsia can progress to eclampsia, a condition that involves severe symptoms such as seizures and even death. The warning signs of preeclampsia are often vague, including symptoms like edema (swelling) and headaches[^1^]. This makes it difficult to identify which patients are at a higher risk for adverse outcomes.

The Revolutionary Blood Test

Developed by Thermo Fisher Scientific, the blood test is designed for pregnant women in the 23rd to 35th weeks of pregnancy. By measuring the ratio of two proteins produced by the placenta, the test can accurately determine the likelihood of developing severe preeclampsia[^1^]. A study conducted on over 1,000 pregnant women with high blood pressure found that these proteins were highly unbalanced in those who later developed severe preeclampsia[^1^]. These findings were published in NEJM Evidence, further solidifying the validity and reliability of the blood test.

Saving Lives and Ensuring Better Care

The approval of this blood test has significant implications for pregnant women at risk of preeclampsia. Previously, the only course of action to manage preeclampsia was early delivery of the baby, which is not an ideal solution[^1^]. However, with the blood test, healthcare professionals can accurately predict the onset of preeclampsia and take appropriate measures to ensure the well-being of both the mother and the baby.

The blood test provides essential information to guide clinical decisions. Women who test negative can be safely discharged from the hospital, relieving unnecessary stress and hospital stays. On the other hand, two-thirds of women who test positive will advance to severe preeclampsia and may require early delivery[^1^]. Identifying these cases can facilitate timely interventions and potentially save lives.

Addressing Disparities in Preeclampsia Care

Preeclampsia disproportionately affects Black women, with higher rates compared to white women. Black women are also more likely to experience kidney damage, death, and other adverse outcomes for both themselves and their babies[^1^]. The availability of this blood test can help address these disparities by ensuring early detection and better management of preeclampsia in this high-risk population.

Looking Ahead

The FDA approval of this blood test marks a significant milestone in the field of maternal-fetal health. With its high accuracy rate and ability to predict the onset of preeclampsia, this test has the potential to save lives and improve the quality of care for pregnant women. Further research and advancements in preeclampsia diagnostics will continue to drive progress in maternal health, ensuring safer pregnancies and healthier outcomes for both mothers and babies.

References:

[^1^] “A New Blood Test for Preeclampsia Is ‘Revolutionary’,” The New York Times. Read Here

More Information:

For more information on preeclampsia, visit The March of Dimes.

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