A large randomized trial found that a mid-pregnancy blood test paired with targeted interventions improved neonatal outcomes in low-risk pregnancies.
A large randomized controlled trial found that use of a mid–second-trimester maternal blood biomarker test, combined with targeted preventive interventions for those identified as higher risk, significantly improved neonatal outcomes in pregnancies otherwise considered low risk for spontaneous preterm birth.1,2
Findings were published in PREGNANCY, the peer-reviewed journal of the Society for Maternal-Fetal Medicine, and were based on results from the PRIME trial (NCTNCT04301518), which enrolled more than 5,000 pregnant individuals across the United States.
PRIME was a multicenter, randomized, controlled trial conducted at 19 sites in the United States. Participants with singleton pregnancies at 18–20 6/7 weeks’ gestation underwent biomarker testing using the insulin-like growth factor–binding protein 4 to sex hormone–binding globulin (IGFBP4/SHBG) ratio, a previously validated blood-based predictor of spontaneous preterm birth risk. Participants were then randomized to either an open-label, screen-guided care arm or a blinded routine care arm.
Those identified as higher risk in the screen-guided care arm received intervention consisting of daily vaginal progesterone, low-dose aspirin, and weekly telephonic nurse support, while participants in the routine care arm continued with standard prenatal care. The enrolled population included 5,018 participants, with delivery data available for 4,806 individuals in the intent-to-treat analysis.
The PreTRM Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, according to Sera Prognostics, Inc.2
Screen-guided care was associated with statistically significant improvements across the co-primary outcomes. Compared with routine care, the intervention strategy reduced the odds of composite neonatal morbidity and mortality (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.66–0.96; P = 0.015) and shortened neonatal hospital length of stay (incidence rate ratio [IRR], 0.95; 95% CI, 0.92–0.98; P = 0.004). Fewer neonatal intensive care unit (NICU) admissions were also observed among infants in the screen-guided care group.1
Complementing these findings, the press release reporting on the study highlighted several clinically meaningful outcomes, including “56% and 32% fewer babies were born before 32 and 35 weeks, respectively,” along with “20% fewer babies admitted to the NICU” and a “20% reduction in odds of neonatal morbidity.” The investigators also reported that 1 NICU day was saved for every 4.2 patients screened using the test-and-treat strategy.2
“The PreTRM Test represents a meaningful step forward in how we identify and manage risk for preterm birth,” said Brian Iriye, MD, principal investigator for the PRIME study. “By quantifying a woman's biologic risk early in pregnancy, the PreTRM Test allows us to move beyond guesswork and implement a straightforward, low-burden, evidence-based care plan that supports her, protects her baby, and improves outcomes for the families we serve—while reducing the downstream cost and complications of being born too soon."
Importantly, PRIME excluded women with prior spontaneous preterm birth or premature cervical shortening at enrollment, underscoring the relevance of the findings for populations not typically flagged by current screening approaches. The study population was diverse, with no significant demographic differences between treatment and control groups. Investigators noted that the strategy demonstrated greater efficiency than standard care, with approximately 39 women needing to be screened to prevent one NICU admission, compared with 150 using current approaches.
The authors concluded that IGFBP4/SHBG screen-guided care, combined with targeted interventions, may enhance early risk detection and inform strategies to reduce events related to preterm birth in low-risk pregnancies.1
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