A national randomized trial that pulled in Austin obstetricians has found that a simple midpregnancy blood test, paired with a short course of targeted preventive care, significantly cut the earliest preterm births and reduced the need for neonatal intensive care. The PRIME study followed 5,018 pregnant people across 19 U.S. sites and saw notably fewer deliveries before 32 weeks of pregnancy and fewer NICU admissions in the group that was screened and then treated based on their results.
The full data, published Jan. 7 in the Society for Maternal-Fetal Medicine journal Pregnancy, showed that the screen-guided care arm had roughly 56% fewer births before 32 weeks, 32% fewer before 35 weeks, and about 20% fewer NICU admissions compared with routine care. Investigators also reported fewer newborn complications overall and a measurable drop in NICU length of stay for babies whose mothers were screened and then received the targeted interventions.
How the Test and Care Bundle Work
Participants had a single blood draw in midpregnancy, between 18 0/7 and 20 6/7 weeks of gestation, and researchers measured the IGFBP4:SHBG biomarker ratio, according to ClinicalTrials.gov. The study randomized people 1 to 1 into a screen-guided care arm, which received test results, and a routine care arm, which did not. About 15% of participants screened as higher risk. Those patients were offered a prevention bundle of daily vaginal progesterone, low-dose aspirin, and weekly nurse check-ins, as laid out by Contemporary OB/GYN.
Austin Patients and Clinicians in the Mix
The Women’s Center of Texas at St. David’s North Austin Medical Center was one of the PRIME sites, which means Austin-area residents were part of the trial. One of them, Samantha Wallin, told the Austin American-Statesman that her first son was born at 38 weeks and her second arrived at 39 weeks after she enrolled in the study. St. David’s obstetrician,n Dr. Molly McDonal,d told the Austin American-Statesman, “Every day less in the NICU is one that you get to spend at home.”
Price Tags, Coverage and What Comes Next
The test currently uses a proprietary CPT/PLA code that Medicare priced at $750 in 2021, but broad insurance coverage is still limited, and many state Medicaid programs do not reimburse for it, according to Sera Prognostics’ filing with the SEC. In a company release distributed via PR Newswire, lead investigator Dr. Brian Iriye called the PRIME findings “a meaningful step forward,” and the company said it is working with insurers and piloting programs with Medicaid plans to expand access.
What Doctors Are Watching Now
Obstetricians and researchers have described the PRIME results as promising but say they want to see independent review, replication, and detailed economic studies before this kind of screening becomes routine care. Specialist coverage has noted that the biggest clinical gains were concentrated among the very earliest preterm births and that insurers will likely expect more data on cost-effectiveness and real-world outcomes, as reported by Contemporary Pediatrics…