Unlocking the prediction of preeclampsia, a widespread, life-threatening pregnancy complication

Preeclampsia affects 8.5 million women every year.1 Innovative test is the key to identifying women at risk

What is preeclampsia?

A disease occurring during pregnancy that impacts more than 1 in 20 women worldwide,2 preeclampsia represents a significant threat to women’s health. The condition involves reduced blood flow from the placenta and inadequate oxygen and nutrients to the foetus which if left undetected, can lead to serious health consequences for both mother and baby. Globally, the condition causes 15 per cent of all premature births and 42 per cent of all maternal deaths.2

The costs of poor prediction

Many of the early symptoms of preeclampsia resemble the normal effects of pregnancy on the body and so are difficult to pinpoint. Standard diagnosis involves detecting high blood pressure after 20 weeks and protein in the urine. Yet both indicators are poor predictors of which women will develop adverse outcomes and which will go on to have normal pregnancies.

Approximately 80 per cent of pregnant women with signs of preeclampsia do not develop the condition.Often, these women are unnecessarily hospitalised, causing the mother anxiety and increasing the overall cost of treatment. Health care providers spend an estimated US$120 billion every year treating preeclampsia.1,4

An innovative new approach for triage of women with suspected disease

Recognising that early detection and effective care can vastly reduce the number of preeclampsia-related deaths, a novel preeclampsia test has been developed that measures the two proteins* found in the mother’s blood. The test can predict which pregnant women with suspected preeclampsia will and will not develop the condition with greater certainty than standard diagnostics, giving doctors the confidence to send healthy women home safely and to focus patient management on women who are more likely to develop preeclampsia.

Enhanced predictions benefitting patients and care providers

A recent study looked at the impact of the new test on more than 1,200 pregnant women suspected of having preeclampsia in 30 sites in Europe, Canada, South America, Australia and New Zealand. The PROGNOSIS study, published in the New England Journal of Medicine, shows that the test predicts which women will not develop preeclampsia in the next week with more than 99 per cent confidence.3 Additional benefits include:

  • The predictive value for clinicians: By determining the absence of preeclampsia for one week, and the development of preeclampsia within the subsequent four weeks, the test gives doctors the insight needed to predict or rule out preeclampsia early.
  • The significant benefits to patients: The negative predictive value saves women who are unlikely to develop the condition the stress of close monitoring, the disruption of a hospital stay and the costs associated with additional treatment, whilst at-risk patients can receive specialised care.
  • Reduced hospitalisation and greater cost savings. By using the new test in clinical practice, the hospitalisation of women suspected of having preeclampsia could be reduced by 50 per cent, leading to cost savings of 399 GBP per patient.5Annual UK savings are projected to be >£16 million.6

Roche recognises the enormous medical and economic value of diagnostics for both patients and health care providers. By facilitating proactive disease management, the new preeclampsia test enables more efficient and effective care for women in need.

*sFlt-1/PlGF ratio: ratio between soluble fms-like thyrosine kinase 1 (sFlt-1) and Placental Growth Factor (PlGF)

Potential for timely detection of complications

Dr. Maria Schödl, Study Manager, Clinical Operations, Medical and Scientific Affairs

“Preeclampsia testing gives pregnant women more confidence,” says Dr. Maria Schödl, Study Manager, Clinical Operations, Medical and Scientific Affairs, Penzberg who was in the team leading the PROGNOSIS study that showed the relevance of the sFlt-1/PlGF ratio for predicting impending preeclampsia.

“In the past, preeclampsia was also called the “disease of theories,” said Maria. “Even today, the causes are still not completely clear. But we do know that in the course of the disease, the blood flow through the placenta becomes abnormal. During the ongoing study, I became pregnant with my first child. It was an irony of fate that I developed preeclampsia myself, which the doctors did not diagnose in time. The severe symptoms occurred directly after my daughter’s birth, so she was fortunately not affected. I too came through the disease without complications. If the results of the study had already been available at the time, I could have benefited from that myself. During my second pregnancy, I had my sFlt-1/PlGF value regularly checked at a hospital so as to rule out the possible occurrence of preeclampsia. Fortunately, everything went well.”

Since then, the sFlt-1/PlGF ratio has been introduced into clinical guidelines in the UK which recognise its utility alongside standard clinical assessment and follow-up to help to accurately and quickly rule out the development of pre-eclampsia in patients with suspected disease. This means patients can be discharged secure in the knowledge that they are not at risk of developing pre-eclampsia over the next seven days.

The sFlt-1/PlGF ratio could help reduce UK hospitalisations by 50 per cent,5 resulting in significant savings for the National Health Service and also freeing up hospital beds to allow clinicians and midwives to care for those patients most in need.

“This certainty spares pregnant women an unnecessary hospital stay and also decreases the burden on the health system in the long term,” concludes Maria.

References

1 Anderson, U.D., Olson, M.G., Kristensen, K.H., Åkerström, B., & Hansson, S.R. (2012) Review: Biochemical markers to predict preeclampsia. Placenta. 33(suppl), S42-7.
2 Verlohren, S., Galindo, A., Schlembach, D., Zeisler, H., Herraiz, I., et al. (2010). An automated method for the determination of the sFlt-1/PIGF ratio in the assessment of preeclampsia. Am J Obstet Gynecol. 202(2), 161.e1-161.e11.
3 Zeisler, H., Llurba, E., Chantraine, F. et al. (2016). Predictive Value of the sFlt-1: PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 374, 13-22.
4 Meads, C.A., Cnossen, J.S., Meher, S., et al. (2008). Methods of prediction and prevention of pre-eclampsia: systematic reviews of accuracy and effectiveness literature with economic modelling. Health Technol Assess. 12(6), iii-iv.
5 Strunz-McKendry, T., Allegranza, D., Hund, M. et al. (2014). UK cost-effectiveness analysis of incorporating the sFlt-1/PlGF ratio test into standard clinical practice for diagnosis of pre-eclampsia and/or HELLP syndrome. World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI), 2014. Paris, France. P73.
6 Data on File: DOF_sFlt/PIFGa_05_16

Tags: Patients