A new screening tool could detect preeclampsia risk sooner, a test developer says.-Waukeshahealthinsurance.com

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A new blood test can be done in a pregnant woman First trimester to assess risk of preeclampsia, a life-threatening pregnancy complication.

is it. The first and only test of its kind available in the United States can be used between 11 and 14 weeks of pregnancy to determine the risk of preeclampsia before 34 weeks of pregnancy, the manufacturer, LabCorp, announced Wednesday. of First trimester It is from 0 to 13 weeks of pregnancy.

However, the new test does not change clinical guidelines on preeclampsia. according to American College of Obstetricians and Gynecologists, also known as ACOG. Some doctors ask how it helps.

“Currently, it is not clear how useful the LabCorp test will be in accurately predicting the risk of early preeclampsia and whether it is appropriate for all pregnant patients,” said Dr. Christopher Zahn, ACOG's interim CEO and director of clinical practice and health equity and quality. In the description.

“Before screening can be successfully employed, evidence-based interventions are needed to prevent or reduce the impact of disease. Currently, we have no information on how a blood test early in pregnancy can rule out a pregnant patient suspected of having preeclampsia, as opposed to clinical conditions.

Preeclampsia a Pregnancy complications High blood pressure and high levels of protein in the urine or other signs of organ damage. The situation It usually develops after 20 weeks Pregnancy – in the second month – and if not treated, it can be serious or fatal for both the mother and the baby.

There is no cure for preeclampsia, other than giving birth, but there are some Severe cases can be treated with medication such as anti-hypertensive drugs.

Some reasons that can make a person pregnant Risk of preeclampsia Include being over 35; Being pregnant for the first time; Overweight Having a family history of preeclampsia; diabetes, high blood pressure, kidney disease or autoimmune disease; having twins or triplets; or in vitro fertilization.

The new screening test assesses any patient's risk of preeclampsia at 34 weeks' gestation, the third trimester, and provides an overall risk assessment of up to 90% sensitivity and 90% specificity, according to Labcorp. Sensitivity refers to the ability to accurately identify high-risk pregnancies, while specificity refers to the ability to accurately identify non-high-risk pregnancies.

Doctors who think their patients might benefit from this screening can talk to their patients about the option, order the test, and get the results within days.

“This is one more tool in the tool belt for clinicians in the US and beyond,” said Dr. Brian Caveney, LabCorp's chief medical and scientific officer. In Care Of 1 in 25 pregnancies in the United States It is affected by preeclampsia, and it is one of the main causes of maternal death.

Options for preeclampsia risk screening are limited. Before the new test, at-risk patients could only be diagnosed with preeclampsia in the second or third trimester of pregnancy if they had both symptoms and hospitalization, and even The test started last year.

The new first-trimester test is not a diagnostic test, but a risk assessment tool to determine if a person is at higher than average risk of developing preeclampsia during the current pregnancy, “along with other questions your doctor might ask at the first three-month visit,” Caveney said.

The screening results “may result in small changes in the prenatal care you receive from your doctor, based on the results of this risk prediction tool.” he said.

Those changes may include making more doctor visits to monitor your pregnancy, checking your blood pressure at home at least once a week, not overdoing it during exercise or at work, or taking more than your doctor recommends. Prevention of low-dose aspirin.

of The US Defense Services Task Force advises. Use of low-dose aspirin as prophylaxis after 12 weeks of pregnancy in people at high risk for preeclampsia, but some people and their providers may not know they are at high risk, especially if it is their first pregnancy.

“At least half or more of the cases of preeclampsia are preventable,” Caveney said. “If you know early in pregnancy, you can do things that will lead to a healthy pregnancy and hopefully a healthy birth.”

The new screening test is a laboratory-developed test, or LDT, and does not require approval from the US Food and Drug Administration.

Labcorp is in talks with health insurance plans to make sure the test is covered, Caveney said, adding that the list price for the screening is $240.

There are also racial differences in the risk of preeclampsia. It is the proportion of black women in the United States. 60% higher than white women. In general, black women are three times more likely to die from pregnancy-related causes than white women US Centers for Disease Control and Prevention.

“Preeclampsia is one of the leading causes of significant disparity in maternal outcomes,” Caveney said. “With a focus on health equity, we hope that better, evidence-based preeclampsia screening, along with more social and health services and prenatal care, will help 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, those biomarkers are placental growth hormone, or PIGF, in the blood. Pregnancy-associated plasma protein-A or PAPP-A in the blood; Blood pressure measurement is the average blood pressure in the arteries; and the patient's uterine artery pulsatility index, or UtAPI, measured during ultrasound.

Having a low level of PlGF and PAPP-A can indicate that the placenta is developing and working poorly, according to Labcorp, high arterial pressure and UtAPI can indicate an increase in blood pressure and a decrease in blood flow in the uterine artery.

A study was published in 2018 In the journal Ultrasound in Obstetrics and Gynecology Screening performance was “significantly improved” when the screening method included maternal factors along with biomarkers such as mean arterial pressure, UTAPI, PIGF and PAPP-A.

Not all doctors recommend the new screening test for their patients.

“The test's usefulness in managing patients has yet to be proven, and it's unclear whether it will help more than it may harm,” said Dr. Christian Petker, MD, chief of fetal medicine and professor at Yale-New Haven Hospital. Yale School of Medicinethey wrote in an email.

“It is not clear to me that this is appropriate for all patients who are pregnant in the first trimester. Perhaps the most applicable group is for patients who have experienced preeclampsia in earlier periods of pregnancy, although these patients are already at high risk and often follow different paths in their pregnancy, “Peter wrote.

“While the test is somewhat good at predicting which patients will develop preeclampsia, it is unclear how many patients will develop preeclampsia,” he added. “I do not underestimate the number of patients affected by false positives.”

ACOG agrees that Zahn's fake reviews come with risks.

“With any new screening tool, it's always important to make sure the benefits outweigh the risks,” Zahn said.

Petker also explained how the test is done to assess the patient's risk of preeclampsia based on biomarkers and how the ultrasound measurement of uterine artery blood flow is “not a routine test performed by ultrasound rooms or doctors and requires special knowledge and training.”

Labcorp plans to speak With physicians and maternal-fetal specialists about the test's components, Kaveney said, however, the screening test can still be ordered using blood-based biomarkers and regular blood pressure readings.

“More information is better, but not necessary, which means that this test works better statistically if we get all the information from the doctor. However, not every obstetrician's office or ultrasound center routinely has the ability to calculate this uterine artery pulse index,” he said.

“If they don't, we still give the test and a risk marker. It reduces our sensitivity or our ability to accurately predict the risk of preeclampsia,” he said. “It's about 90% in the high 70s, which is much better than just assessing traditional maternal risk factors.”

Eleni Tsigas, chief executive of the Preeclampsia Foundation, said a screening tool like the new first-trimester test could have “significantly” changed her pregnancy experience if it had been available during her first pregnancy in 1998.

“My daughter died and it happened because of a last minute emergency,” she said.

Tsagas was diagnosed with preeclampsia 11 weeks before her due date, and her daughter Niconia Evangelia Tsagas was stillborn due to preeclampsia.

Tsigas said at the time that there was only one thing that put her at risk: the girl was her first pregnancy.

“But losing your first child shouldn't be a high-risk screening test,” Tsigas said. “Many people are treated with complete caution when they develop preeclampsia in their first pregnancy, because they didn't have these risk factors other than in their first pregnancy.”

Tsegas and her husband had two more children after that first pregnancy; Their sons Jordan and Jonathan. For those pregnancies, she said, she and her care team were aware of the risk of preeclampsia, monitored her health closely, and took low-dose aspirin when recommended by her doctor.

But according to the newly launched primary screening test, “if done right, it has the potential to remove…

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