A new screening tool allows for the identification of preeclampsia risk at an earlier stage, according to its manufacturer.

The newly developed screening device allows for the early detection of preeclampsia, according to its manufacturer.

Announced on Wednesday, Labcorp has created the first and only test in the US that can be conducted between 11 and 14 weeks into a pregnancy to determine the likelihood of developing preeclampsia before reaching 34 weeks. The first trimester of a pregnancy lasts from 0 to 13 weeks.

However, this new test does not alter the professional guidance on preeclampsia, as stated by the American College of Obstetricians and Gynecologists (ACOG). Some physicians question its usefulness.

"It remains uncertain how the LabCorp test will accurately predict the risk for developing preeclampsia, and whether it's suitable for all pregnant individuals," stated Dr. Christopher Zahn, ACOG's interim CEO and chief of clinical practice and health equity and quality.

"For a screening test to be effectively implemented, there must be an evidence-based intervention to either prevent or reduce the severity of the disease. At present, we have no data on how to lower the risk of preeclampsia in pregnant women based on a blood test at the start of their pregnancy instead of clinical factors," he added.

Preeclampsia is a pregnancy complication characterized by elevated blood pressure and high urinary protein levels or other signs of organ damage. This condition generally emerges after the 20th week of gestation, in the second trimester. If left untreated, it can become life-threatening for both mother and child.

Despite having no cure for preeclampsia outside of delivering the baby, some grave cases can be managed using medications like antihypertensive drugs.

Factors that could put a pregnant individual at risk for preeclampsia include being over 35 years old, being pregnant for the first time, having obesity, having a family history of preeclampsia, having diabetes, high blood pressure, kidney disease or an autoimmune condition, having twins or triplets, or having gone through in vitro fertilization.

The new screening detects the risk of preeclampsia by 34 weeks, which is the final trimester, and offers a comprehensive evaluation with up to 90% sensitivity and 90% specificity, according to Labcorp. Sensitivity refers to a test's ability to accurately identify pregnancies with a higher risk, while specificity refers to its ability to correctly identify pregnancies with a lower risk.

During a discussion with their patients, doctors can suggest the screening option, order the test, and get results in a few days.

"This is one more tool for physicians in the US and worldwide to help enhance the maternal outcomes," stated Dr. Brian Caveney, Labcorp's chief medical and scientific officer. About 1 in 25 pregnancies in the US are influenced by preeclampsia, which is also one of the leading causes of maternal death.

Preeclampsia risk screening options were previously restricted. Before this new test was introduced, high-risk patients could only screen in the second or third trimester if they were symptomatic and hospitalized, with this test being recently launched last year.

This first-trimester test is not a diagnostic test but a risk assessment aid to determine if someone is more likely than normal to develop preeclampsia during their present pregnancy, according to Caveney. "[The test] can be combined with all the other queries your physician might ask you during a first-trimester appointment," he said.

The results of the screening could result in "a variety of modifications in the prenatal care you receive from your healthcare professional, based on the outcomes of this prediction tool early on." These changes may involve increased doctor visits to monitor your pregnancy, checking your blood pressure at home at least once a week, being thoughtful about exerting yourself during exercise or work, or, if recommended by your doctor, taking low-dose aspirin prophylactically.

The US Preventive Services Task Force recommends using low-dose aspirin as a preventive medication after 12 weeks of gestation for individuals at high risk for preeclampsia, yet many individuals and their healthcare providers may be unaware of their elevated risk, particularly if it is their first pregnancy.

"At least half or more of preeclampsia cases could be avoidable," Caveney said. "If you identify it earlier in the pregnancy, you're more likely to take actions that result in a healthier pregnancy and ultimately, a healthier delivery."

The newest screening test is a laboratory-developed test (LDT), so it does not demand approval by the US Food and Drug Administration to be used.

Labcorp is in negotiations with medical insurance providers to guarantee that the test is covered. The screening assay's cost is approximately $240.

How the risk assessment works

Racial disparities exist in preeclampsia risk as well. In the United States, the rate for Black women is roughly 60% higher than for White women. In general, Black women are three times more likely to die from a pregnancy-related cause than White women, according to the US Centers for Disease Control and Prevention.

"Preeclampsia is a major factor contributing to the unequal outcome for mothers," said Caveney. "With the focus on health equity, we believe that enhanced, scientifically-based preeclampsia screening might help improve this, combined with a variety of social and health services and prenatal care to hopefully improve pregnancy results not just in the US, but worldwide."

A new screening method works by spotting and measuring four compounds in the blood related to preeclampsia. The compounds are the placental growth factor or PIGF hormone; pregnancy-associated plasma protein-A or PAPP-A; the patient's average arterial blood pressure; and the patient's uterine artery pulsatility index (UtAPI) assessed during an ultrasound.

Preeclampsia may be predicted by low levels of PIGF and PAPP-A because they suggest inadequate placenta development and function. High levels of arterial pressure and UtAPI show elevated blood pressure and diminished blood flow in the uterine artery.

A study published in 2018 in the medical journal "Ultrasound in Obstetrics and Gynecology" observed that the accuracy improves dramatically for screening when maternal factors, including arterial pressure, UtAPI, PIGF, and PAPP-A, are added to the equation.

Doubts from some professionals

Not every medical practitioner is on board with recommending the new screening test.

"There's still a need for proof that it can improve management of patients," said Dr. Christian Pettker, head of obstetrics at Yale-New Haven Hospital and a professor at Yale School of Medicine. "We simply don't know if it's better than the current prenatal care standards. The purpose of a screening test is to help more than it may potentially harm. The true value of this test is not yet clear."

Pettker clarified that the test may be appropriate for high-risk patients, such as those with a previous history of preeclampsia, "but these women are usually followed more closely during their pregnancy anyway."

"While the test accurately predicts preeclampsia, it's unclear how many patients falsely assume they'll develop it. The number of individuals who could be influenced by a false positive should not be underestimated," he said.

ACOG's Zahn acknowledged that false assessments bear some risks. "With any novel screening technique, it's essential to ensure that the advantages surpass the drawbacks," Zahn noted.

Pettker also had reservations concerning the procedure of assessing a person's preeclampsia risk using biomarkers rather than a standard ultrasound blood flow evaluation, which demands specific training and competence.

Despite this, Caveney mentioned that Labcorp would engage with physicians and maternal-fetal experts about the screening test's components. "We'll be talking with physicians and maternal-fetal specialists about the various parts of the test," he said. Nevertheless, Labcorp also mentioned that the test could still be carried out using blood-based biomarkers and regular blood pressure readings if ultrasound-related data is unavailable.

"While having all of the data is preferable for optimum statistical accuracy, it's not necessary. The test performs best with the biomarkers and blood pressure readings alone. But if they don't provide the UtAPI measurement, it decreases the test's ability to identify the new risk of preeclampsia. Instead of a 90% sensitivity, it drops to the upper 70s," he said.

More awareness could've saved a child

Eleni Tsigas, CEO of the Preeclampsia Foundation, shared her view that a screening tool like the first-trimester test could have made a significant difference in her first pregnancy in 1998.

"My daughter died as she was stillborn due to complications from preeclampsia," she said. "The sole risk factor at the time was that it was my first pregnancy."

"Losing your first baby should not be the screening test for being at a high risk," Tsigas said. "So many individuals are surprised to develop preeclampsia during their first pregnancy, since they lacked other risk factors beyond it being their first."

Tsigas and her spouse went on to have two more children after that first pregnancy: their sons Jordan and Jonathan. For these pregnancies, Tsigas and her team closely monitored her health and took her doctor's advice to take a low-dose aspirin.

Join us here to receive "The Results Are In" with Dr. Sanjay Gupta every Tuesday via CNN Health.

Tsigas highlights, "The recently introduced first-trimester screening test could prevent surprising instances of preeclampsia if executed correctly."

She accentuates, "The term 'done right' implies discouraging the addition of a tool inaccessible to specific individuals, potentially exacerbating disparities."

"Decent coverage by insurance providers, awareness-building, and making this information available to all women, irrespective of socio-economic background, are crucial for utilizing this test effectively," Tsigas states. "In doing so, we can reduce the gaps in maternal health outcomes and neonatal health outcomes, significantly improving healthcare services."

Read also:

This new test, developed by Labcorp, does not alter the current guidelines for managing preeclampsia as suggested by ACOG. (ACOG's Zahn)

Despite the new test's ability to identify pregnancies with a higher risk of developing preeclampsia with up to 90% sensitivity and specificity, there is currently no evidence-based intervention to lower the risk of preeclampsia for pregnant women based on blood test results at the start of their pregnancy. (ACOG's Zahn)

Source: edition.cnn.com