SERA PROGNOSTICS COMPLETES ENROLLMENT FOR PREVENT PTB CLINICAL INTERVENTION STUDY USING PreTRM® TEST
Announcement of End of Enrollment
Sera Prognostics, Inc., the leading health diagnostics company dedicated to improving the lives of women and babies through individualized prenatal care, announced on February 19, 2019 that investigators at Intermountain Healthcare in Salt Lake City, UT, have ended enrollment into the PREVENT PTB study.
First announced in May 2018, the PREVENT PTB study was the first study of its kind to use Sera’s innovative PreTRM® blood test to identify women at high risk for premature birth, and, in those individuals, to evaluate the impact of proactive interventions designed to prolong pregnancy and reduce the rate of premature delivery. (ClinicalTrials.gov Identifier: NCT03530332)
The prospective randomized controlled PREVENT PTB trial is groundbreaking. The study is examining the impact of the PreTRM® strategy in both the test-treat arm (subjects who have received the PreTRM® test) and the control arm (subjects who have not). In test-high patients, multiple simultaneous proactive interventions that are designed to decrease the severity and frequency of preterm birth.
Final results of the study are projected to be read-out before year-end 2019 and submitted for scientific review and presentation at an upcoming medical conference.
About Preterm Birth
According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity. Of nearly 4 million babies born annually in the U.S., approximately one in ten is born prematurely.1 Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. Approximately $32B of expense occurs annual as a result of premature birth. 2
About the PreTRM® Test
The PreTRM® test is the only clinically-validated blood test that provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® test can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk. The PreTRM® test is ordered by a medical professional. For more information about the PreTRM® test, please visit www.PreTRM.com and the PreTRM® test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.
2 Caughey et al, Am J Perinatol Rep 2016;6:e407-e416