Preeclampsia Diagnostic Test May Also Predict Onset

Interim results of a clinical study suggest that a serum test in use for preeclampsia diagnosis may also help predict the disease, which would help in early identification of many women at high risk of developing preeclampsia.

The potential for extended use of the Roche (Basel, Switzerland) automated diagnostic Elecsys test for preeclampsia is being examined in a study, named PROGNOSIS, on prediction of short-term outcome in pregnant women with suspected preeclampsia. The study has more than 1,200 subjects enrolled from 14 countries worldwide. Presented at the 18th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI) held in Vienna in October 2013, the study is investigating the correlation between the ratio of two proteins (sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor)) in maternal blood and the risk of developing preeclampsia over the subsequent 4 weeks. Interim analysis of the data from the first 500 patients included in the study showed promising results. It also showed an approximately 20% prevalence of preeclampsia in the target population.

Based on the initial results, the study is expected to lead to improvement in the short-term prediction of preeclampsia and thus to help physicians identify patients at highest risk, improving clinical outcome and healthcare resource allocation. If the full study yields its anticipated results, the possibility of using an automated test to predict the disease would enable healthcare professionals to focus on patients at highest need of appropriate and timely clinical intervention before the development of full-blown preeclampsia. Likewise, patients identified as unlikely to develop the disease can be discharged from hospital.

“PROGNOSIS has a study design that is unseen in the last 20 years of preeclampsia research,” said Annetine Staff, professor of the Department of Gynecology at the Women and Childrens Division at Oslo University and PROGNOSIS principal coordinating investigator. “The PROGNOSIS study will expand the use of these powerful markers for preeclampsia from the very good performance for aid in diagnosis towards the area of prediction and early risk stratification,” said Harald Zeisler, professor of the Department of Obstetrics & Gynecology of the Medical University Vienna and site principal investigator for the PROGNOSIS study; "We hope that early identification of women at high risk of developing preeclampsia will allow healthcare professionals to prevent the most serious effects of the disease and avoid unnecessary expenditure by healthcare systems on excessive medical treatment or unnecessary hospital admission prompted by inadvertently positive diagnoses based on current standard of clinical practice.”

Based on the current guidelines that have remained unchanged for decades, the diagnosis of preeclampsia is based on the clinical parameters of hypertension and proteinuria, which are neither specific nor sensitive. In addition, clinical criteria alone may be inadequate for predicting the disease and especially its adverse outcomes, hence the decision to run the PROGNOSIS study addressing an important unmet medical need. PROGNOSIS is a multicenter, prospective, double blind and noninterventional trial evaluating the short-term prediction of preeclampsia, eclampsia and HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome in pregnant women with suspected preeclampsia. The study began enrolling in December 2010 at 9 sites in Western Europe and in 2012 was expanded to 31 sites worldwide across Australia, Canada, New Zealand, and Latin America.

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