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Pre-eclampsia Testing

Preeclampsia is a pregnancy complication affecting between two and eight out of every 100 pregnant women.

The exact cause is unknown, but its risks are clear: left untreated, preeclampsia can cause growth-restriction or preterm birth of the child, and in some cases, lead to maternal and perinatal mortality. But with screening, the more severe forms of pre-eclampsia, early-onset and preterm preeclampsia, could be predicted and prevented.

Early screening and better care - solutions for effective pre-eclampsia management
 

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When it comes to preeclampsia prevention, the earlier you identify women as having a high risk for developing the condition, the better the outcome for mother and child. Based on evidence from research studies, such as the ASPRE study, a combined screening program is recommended at 11–13 weeks' gestation to identify women at high risk of preeclampsia, when steps can still be taken to prevent its onset.

Later in the pregnancy 20 weeks onwards, angiogenic markers can be used to help identify women with increased risk for developing preeclampsia in the coming days. 
 

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Pre-eclampsia Testing

1st trimester: Specific marker for pre-eclampsia - PIGF

In pregnancies that develop preeclampsia, maternal serum placental growth factor (PlGF) levels decrease significantly in the first trimester. This makes it an important biomarker used to predict the onset of preeclampsia. Our high-sensitivity PlGF 1-2-3™ assay is optimized for first trimester screening of preeclampsia and is the only assay which was clinically validated by the ASPRE trial.

The same blood sample can be used for both preeclampsia and aneuploidy screening using the same instrument and markers; no additional blood sample is required.

Combined screening model

Based on the evidence from research studies, international guidelines are recommending a combined screening program for preeclampsia at 11-13+6 weeks as the most effective way to identify women at high risk of pre-eclampsia in the early stages of pregnancy.

The combined screening program is made up of four simple steps that require short training and minimal additional investment In equipment. Our Lifecycle software can generate a unique patient risk profile and report based on these combined screening markers.

  • Medical history
  • PlGF blood test
  • Blood pressure
  • Ultrasound (if available}

2nd and 3rd trimester: PIGF as a single marker or sFlt-1/PIGF ratio

Women with signs or symptoms of preeclampsia do not always develop preeclampsia. Angiogenic markers can be used to help identify women with increased risk for developing preeclampsia in the coming days.

After 20 weeks of pregnancy PlGF and sFlt-1 are both predictive and diagnostic for preeclampsia. Determining serum PlGF concentration, used as a single marker, or sFlt-1 and PlGF, used as a ratio, improve the clinical management and decision making (risk stratification) with women showing signs and symptoms of preeclampsia.

PlGF alone and sFlt-1/PlGF ratio have comparable performance for preeclampsia rule-in and rule-out, and both options are equally recommended for clinical use.  However, PLGF alone, with concentration-based cut-offs, could provide simpler and more affordable alternative to dual biomarker testing.

Using PlGF has additional advantages. Studies have shown that PlGF is a good marker (decreased serum PlGF level) for identifying pregnancies with placental insufficiency including fetal growth restriction and/or stillbirth.

User configurable laboratory data management

Lifecycle™ software enables monitoring of preeclampsia status with PlGF concentration or the sFlt-1/PlGF ratio. The results can be linked to the patient case in Lifecycle™ software allowing the user to track samples and view all available results in one place. The assay cut-offs for preeclampsia management are user configurable and the software can be tailored to population.

References:

Daniel L. Rolnik et al. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. DOI: 10.1056/NEJMoa1704559, New England J Med June 2017 

Wright D et al. Aspirin for Evidence-Based Preeclampsia Prevention trial: influence of compliance on beneficial effect of aspirin in prevention of preterm preeclampsia. Am J Obstet Gynecol. 2017 Sep 6 

Poon LC et al., ASPRE trial: effect of aspirin in prevention of preterm preeclampsia in subgroups of women according to their characteristics and 
medical and obstetrical history. Am J Obstet Gynecol 2017 

Kuklina EV, et al. Hypertensive Disorders and Severe Obstetric Morbidity in the United States. Obstet Gynecol 2009; 113:1299-306 

COMPARE study: Performance of commercially available placental growth factor tests in women with suspected preterm pre-eclampsia, Ultrasound in Obstetric Gynecology​ 

Herraiz et al Update on the Diagnosis and Prognosis of Preeclampsia with the Aid of the sFlt-1/PlGF Ratio in Singleton Pregnancies. Fetal Diagn Ther (2017) PROGNOSIS Hund et al. BMC Pregnancy and Childbirth 2014, 14:324 

ISUOG Practice Guidelines: role of ultrasound in screening for and follow-up of pre-eclampsia, Ultrasound Obstet Gynecol 2018 DOI: 10.1002/uog.20105 

Poon L, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on Pre-eclampsia: A Pragmatic Guide for First-Trimester Screening and Prevention. International Journal of Gynegology & Obstetrics. May 2019 

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