Sera Prognostics’ PreTRM® Test and Treat Strategy Benefits Demonstrated by Results of Prospective, Randomized Controlled Intervention Trial Evaluating Clinical Utility
Study demonstrates positive impact of the company’s PreTRM® test and treat strategy on improving neonatal healthcare
NICU and total hospital length-of-stay in preemies reduced by more than 70%
Faster rate of discharge from the NICU for spontaneous preterm deliveries, any preterm deliveries, and all infant deliveries, respectively
Severe morbidity or newborn death reduced by 66% across all affected infants
SALT LAKE CITY, Aug. 17, 2021 (GLOBE NEWSWIRE) — Sera Prognostics Inc., The Pregnancy Company™, focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the publication, in the American Journal of Perinatology (AJP), https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0041-1732339 of results of the Prediction and Prevention of Preterm Birth (PREVENT-PTB) Study, a prospective, randomized controlled intervention trial conducted between May 2018 through February 2019. The purpose of the trial was to evaluate the impact on neonatal health and economics of applying the company’s PreTRM® test to screen pregnant women for risk of spontaneous preterm birth (sPTB) and treating the women identified at higher risk with proactive interventions. Trial results showed that using PreTRM® to identify and treat those with higher risk pregnancies proactively may lead to better neonatal outcomes.
“We are pleased with the results of this ground-breaking trial and thank the investigators and patients who participated in this study,” stated Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. “This study is the first time that a prognostic biomarker blood test for preterm delivery risk has been evaluated for its potential impact on important outcomes of neonatal health that have large economic consequences. The study results show that promising improvements were obtained by using the PreTRM® test to identify higher risk patients and to intervene more proactively in these pregnancies using well-understood interventions. We believe that these results show that more proactive treatment in patients whose elevated risks are real, but not readily apparent with current clinical methods, can make a positive difference in pregnancy.”
The PREVENT-PTB study, conducted at Intermountain Healthcare, in Salt Lake City, Utah, enrolled 1,208 pregnant patients from May 2018 through February 2019, who were 18 years or older, with a singleton pregnancy in the 19th or 20th week of gestation, and with no history of prior preterm birth and normal cervical length at or before the time of enrollment. Of the 1,181 women ultimately randomized and for whom outcome data were available, 589 pregnancies were in the PreTRM test-screened arm, and 592 served as controls not having access to the test. Patients whose PreTRM test result risk met or exceeded twice the population risk were deemed “higher risk,” and were offered a group of proactive interventions. These included weekly contact with a care management nurse, two preterm prevention clinic visits, cervical length monitoring, weekly injection of 17-alpha-hydroxyprogesterone caproate, daily administration of low-dose aspirin, and the administration of corticosteroid treatment if patients indicated clinical signs or symptoms of imminent delivery. Patients in the screened group found not to be at higher risk by the PreTRM® test received standard obstetrical care. The control group did not receive the PreTRM® test and received standard obstetrical care only.
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