Positive efficacy data of the PreTRM test prevention strategy for reducing rates of severe neonatal morbidity and mortality has been reported by Sera Prognostics Inc.1
Takeaways
- The PreTRM test has shown an 18% reduction in severe neonatal morbidity and mortality in infants of mothers who were tested, compared to a control group.
- Infants whose mothers received the PreTRM test were born, on average, 2.48 weeks later than those in the control group, indicating the test's effectiveness in delaying preterm birth.
- The average neonatal hospital stay was reduced by 7 days, with a significant 28-day reduction for those born before 32 weeks' gestation, showing substantial cost and health benefits.
- The test demonstrated overall reductions in neonatal morbidity, mortality, and NICU length of stay across the entire intent-to-treat population.
- By assessing preterm birth risk at 18-20 weeks of gestation, the PreTRM test allows physicians to make personalized and informed decisions, leading to better health outcomes for both mothers and infants.
According to March of Dimes, at least 1 in 10 US infants were conceived through preterm birth for 5 consecutive years by 2023. Preterm birth is the leading cause of newborn morbidity and mortality, with many long-term medical complications significantly more likely in these patients.
Morbidities seen more frequently in infants born preterm include learning disabilities, chronic respiratory illness, cerebral palsy, seizures, vision and hearing loss, and intellectual disability. These complications led to an approximate $25 billion in health care costs in 2016.1
The PreTRM test is a blood-based biomarker test for use in asymptomatic singleton pregnancies. By assessing proteins in the blood linked to preterm birth, the test provides early, accurate, and individual risk prediction for spontaneous preterm birth.
Using the PreTRM test, physicians can assess preterm birth risk at weeks 18 through 20 of gestation, when the risk of preterm birth and associated complications is increased. This allows physicians to make informed, personalized decisions based on a woman’s risk.1
The efficacy of the PreTRM test was evaluated in the AVERT PRETERM TRIAL, based on the health benefit provided to infants. There were 1463 expectant mothers included in the analysis who received testing mid-pregnancy.
Participants included women aged at least 18 years with a singleton pregnancy between 195/7 weeks’ and 206/7 weeks’ gestational age.2 Pregnancy was confirmed by an ultrasound prior to the analysis, and patients with a prior history of preterm birth were excluded. Screening with the PreTRM test was performed at a tertiary care center.
Patients with an increased risk of spontaneous preterm birth were offered evidence-based interventions such as medications, intensive education, and care management.1 Outcomes were compared to those in a control arm of 10,000 patients in the 2-year period prior to the start of trial enrollment.
Relevant neonatal outcomes included the total length of hospital stay and composite neonatal morbidity and mortality outcomes. Measuring these outcomes, investigators reported an 18% reduced risk of severe neonatal morbidity and mortality in infants of mothers who received the PreTRM test vs controls.
Additional outcomes included a mean reduction in neonatal hospital length of stay of 7 days and increased average gestational age at birth of 2.48 weeks among infants born after use of the PreTRM test. For those born before 32 weeks’ gestation the neonatal length of hospital stay was reduced by 28 days, showing a significant reduction for those at risk of earliest delivery.1
The entire intent-to-treat populations displayed significant reductions in neonatal morbidity and mortality, as well as hospital and neonatal intensive care unit (NICU) length of stay. Additionally, the risks of preterm birth and spontaneous preterm birth were reduced at various gestational ages. Across all pregnancies, NICU length of stay was reduced by 0.6 days.
“These results suggest that biomarker spontaneous preterm birth risk stratification and preventive interventions can ameliorate preterm birth complications in singleton, often nulliparous, pregnancies historically deemed low risk,” said Matthew Hoffman, MPH, endowed chair of the Department of Obstetrics & Gynecology at Christiana Care.1
References
- Sera Prognostics PreTRM test prevention strategy demonstrates 18% reduction in severe neonatal morbidity and mortality in newly published AVERT trial. July 9, 2024. Accessed July 18, 2024. https://www.prnewswire.com/news-releases/sera-prognostics-pretrm-test-prevention-strategy-demonstrates-18-reduction-in-severe-neonatal-morbidity-and-mortality-in-newly-published-avert-trial-302191493.html
- Serum assessment of preterm birth outcomes compared to historical controls: AVERT PRETERM TRIAL. ClinicalTrials. July 13, 2022. Accessed July 18, 2024. https://clinicaltrials.gov/study/NCT03151330
