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A new blood test can be taken from a pregnant person first trimester to help assess their risk of developing preeclampsia, a potentially life-threatening pregnancy complication.
It is It is the first and only test of its kind available in the United States that can be used between 11 and 14 weeks’ gestation to determine the risk of preeclampsia before 34 weeks’ gestation, its manufacturer, Labcorp, announced Wednesday. The first trimester is the period from 0 to 13 weeks of pregnancy.
However, the new test does not change clinical guidelines for preeclampsia, according to the American College of Obstetricians and Gynecologists, also known as ACOG. Some doctors wonder how this could help.
“It is currently unclear how useful the LabCorp test will be in accurately predicting the risk of developing preeclampsia and whether it is appropriate for all pregnant patients,” said Dr. Christopher Zahn, interim CEO of the ACOG and Chief of Clinical Practice, Health Equity and Quality. in a report.
“Before a screening test can be used successfully, there must be an evidence-based intervention to prevent or reduce the impact of the disease. We currently have no data on how to reduce the risk of preeclampsia in a pregnant patient from a blood test early in pregnancy, as opposed to clinical factors,” he added.
Preeclampsia is a pregnancy complication marked by high blood pressure and high levels of protein in the urine or other signs of organ damage. The condition usually develops after 20 weeks of pregnancy – during the second trimester – and if left untreated it can become serious or even fatal for both mother and baby.
There is no cure for preeclampsia, apart from the mother giving birth, but some severe cases can be treated with medications such as antihypertensives.
Some factors that can put a pregnant person at risk for preeclampsia include being over 35; being pregnant for the first time; have obesity; have a family history of preeclampsia; suffering from diabetes, high blood pressure, kidney disease or autoimmune disease; having twins or triplets; or having undergone in vitro fertilization.
The new screening test assesses any patient’s risk of preeclampsia at 34 weeks of gestation, or the third trimester, and provides a comprehensive risk assessment with sensitivity and specificity of up to 90%, according to Labcorp. Sensitivity refers to the test’s ability to accurately identify high-risk pregnancies, and specificity refers to its ability to accurately identify pregnancies that are not high-risk.
Physicians who think their patients might benefit from this screening can discuss this option with them, order the test and get the results within days.
“This is another tool in the toolbox available to clinicians in the United States and beyond to help achieve better maternal outcomes,” said Dr. Brian Caveney, medical and scientific director of Labcorp. In the United States, approximately 1 in 25 pregnancies are affected by preeclampsia, and it is a leading cause of maternal death.
Options are limited for screening for preeclampsia risk. Before the new test launched, at-risk patients could only screen for their risk of preeclampsia during the second or third trimester of pregnancy if they were both symptomatic and hospitalized, and even that test was just launched Last year.
The new first trimester test is not a diagnostic test but a risk assessment tool to determine whether a person is more likely than average to develop preeclampsia during their current pregnancy, “as well as all Other questions your doctor might ask you during your first trimester. quarterly visit,” Caveney said.
The screening results can lead to “a whole series of slight changes in the prenatal care you receive from your doctor, based on the early results of this risk prediction tool,” he said. said.
These changes may involve having more visits to the doctor to monitor your pregnancy, checking your blood pressure at home at least once a week, being careful not to overexert yourself during exercise or at work, or, if your doctor recommends that you take a low-dose aspirin. preventively.
The U.S. Preventive Services Task Force recommends the use of low-dose aspirin as a preventative medication after 12 weeks of gestation in people at high risk for preeclampsia, but some people and their providers may not be aware that they are at high risk, especially if this is the case. is their first pregnancy.
“At least half or more of preeclampsia cases are potentially preventable,” Caveney said. “If you identify it earlier in the pregnancy, you’re more likely to be able to do things that lead to a healthier pregnancy and, in turn, a healthier birth.”
The new screening test is a laboratory-developed test, or LDT, so it does not require approval from the U.S. Food and Drug Administration to be performed.
Labcorp is in talks with health insurance plans to ensure the test could be covered, Caveney said, adding that the screening test has a list price of about $240.
The risk of preeclampsia also has racial disparities. In the United States, the rate among black women is about 60% higher than among white women. In general, black women are three times more likely to die from a pregnancy-related cause than white women, according to the U.S. Centers for Disease Control and Prevention.
“Preeclampsia is one of the main reasons why there is such a disparity in maternal outcomes,” Caveney said. “With a focus on health equity, we believe that more effective and evidence-based screening for preeclampsia could hopefully help address this and many other issues social services, health services, and prenatal care to hopefully improve pregnancy outcomes in the United States and beyond. »
The new screening test works by identifying and measuring four biomarkers associated with the risk of preeclampsia.
According to Labcorp, these biomarkers are the placental growth factor or PIGF hormone in the blood; pregnancy-associated plasma protein A or PAPP-A in the blood; a blood pressure measurement of the average arterial pressure in the arteries; and the patient’s uterine artery pulsatility index or UtAPI, which is measured during an ultrasound.
According to Labcorp, low levels of PlGF and PAPP-A can suggest that the placenta is developing and functioning poorly, while high levels of blood pressure and UtAPI can indicate high blood pressure and decreased blood flow in the placenta. uterine artery.
A 2018 study published in the journal Ultrasound in Obstetrics and Gynecology found that screening performance “is significantly improved” when the screening method includes maternal factors as well as biomarkers, such as measurements of mean blood pressure, UtAPI, PIGF and PAPP-A. .
Not all doctors say they would recommend the new screening test to their patients.
“The usefulness of the test in the management of patients has not yet been proven and it is not clear that it helps more than it could harm. It is not clear that the use of this test is better than current standards of prenatal care,” wrote Dr. Christian Pettker, chief of obstetrics at Yale-New Haven Hospital and professor at the Yale School of Medicine, in an email.
“I’m not sure this is appropriate for all pregnant patients in the first trimester. Perhaps the most applicable group might be patients who had preeclampsia in a previous pregnancy, although these patients are already at high risk and are often followed differently during their pregnancy,” Pettker wrote.
“Although the test is modestly effective in predicting which patients might develop preeclampsia, it is not clear how many patients are incorrectly informed that they will develop preeclampsia,” he added. “I would not underestimate the number of patients affected by a false positive. »
ACOG’s Zahn acknowledged that fake reviews carry risks.
“With any new screening tool, it’s always important to make sure the benefits outweigh the risks,” Zahn said.
Pettker also had some questions about how the test would be administered to assess a patient’s risk of preeclampsia, based on biomarkers, and that ultrasound measurement of uterine artery blood flow “is not not a standard test performed by ultrasound units or doctors and requires very specific expertise. and training.”
Labcorp Plans talk with doctors and maternal-fetal specialists on the components of the test, Caveney said:…
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