Pilot Study to Validate Fetal Medicine Foundation’s Algorithm to Screen Women for the Condition

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that a collaboration for a prospective study in Brazil aiming to validate the Fetal Medicine Foundation’s (FMF’s) algorithm for pre-term preeclampsia.  The FMF algorithm, which is based on a European population, will now be applied to a study group representative of the Brazilian population.

??Conducted by Professor Dr. Fabricio da Silva Costa (Visiting Professor, Department of Obstetrics and Gynecology, Ribeirão Preto Medical School, University of São Paulo) and a team of key researchers at 9 leading medical centers in São Paulo and other Brazilian regions, the study will begin in early 2019 and is expected to take approximately 18 months to recruit 3,500 women. The goal of the study is to have a follow-up implementation study, in which first trimester prediction and prevention measures can be evaluated.  PerkinElmer will provide reagents and software for use in the study.

PerkinElmer is a Bronze Sponsor at the 2018 International Federation of Gynecology and Obstetrics (FIGO) World Congress in Rio de Janeiro.  The FIGOWorld Congress is the single largest annual event on maternal and newborn health, bringing together obstetricians, gynecologists and related health professionals from around the world.

Preeclampsia a condition usually characterized by a sudden increase in blood pressure and protein in the urine, which can occur after the 20th week of pregnancy and often results in pre-term birth.  It can lead to convulsions (eclampsia), renal or liver failure, cardiac, pulmonary and other maternal health complications. Preeclampsia, especially before 37 weeks, often contributes to health complications for the baby including growth restriction, developmental delays due to their prematurity, or even death in some cases.

??Preeclampsia is the leading cause of maternal and perinatal morbidity and mortality worldwide, affecting 2 to 8 percent of pregnancies (1).  Its prevalence can vary from 10 to 18 percent in developing countries (2), and according to the World Health Organization, 25.7 percent of maternal deaths in Latin America and the Caribbean are related to hypertensive diseases in pregnancy. In addition, incidence of preeclampsia may be seven times higher in developing countries than in developed countries (3).  The maternal mortality rate in Brazil is now estimated at 64 out of 100,000 babies.  

??“Preeclampsia is Brazil’s main cause of maternal death and one of the leading causes of perinatal mortality and morbidity. It’s important that we continue to advance our research efforts related to screening and prevention for this condition,helping improve the health of expectant mothers and their developing babies,” said Professor da Silva Costa.

? ?“PerkinElmer is excited to play an invaluable role in this initiative taken by leading researchers in Brazil to evaluate the potential to introduce preeclampsia screening in this region,” said Linh Hoang, MD, PhD, Vice President Reproductive Health Diagnostics, PerkinElmer. “We look forward to additional collaborations globally with researchers in other emerging regions so that more women can have access to screening for preeclampsia.”

FIGO is a not-for-profit, professional association with 130 member organizations dedicated to improving women’s health and reducing disparities in available healthcare to women and newborn babies, along with advancing the science and practice of obstetrics and gynecology.

??PerkinElmer recently announced a collaboration with FIGO to sponsorFIGO’s Non-Communicable Disease (NCD) Committee through an annual unrestricted educational grant.  The Committee focuses on prediction (ideally in the first trimester) and prevention of pregnancy related complications such as pre-eclampsia, pre-term labor, hyperglycemia in pregnancy, and fetal growth restriction as a consequence of common NCDs.  

??PerkinElmer’s DELFIA® Xpress PlGF 1-2-3TM assay was also integral to the ASPRE study, an EU FP7 funded, double blind, randomized study, of aspirin treatment (150mg) to women identified as high risk using a combination of maternal history, biophysical markers and PlGF -1-2-3 TM assay results.  The study was published in the New England Journal of Medicine in June 2017 (Rolink D et al, 2017). Further analysis of the ASPRE data recently published in the American Journal of Obstetrics & Gynecology (Wright D et al, 2018).

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