Hera Women's Health Highlights Sera Prognostics PRIME Trial Results Led by Brian K. Iriye, MD Showing Biomarker-Guided Care Improves Newborn Outcomes and Reduces NICU Use
PR Newswire
LAS VEGAS, Jan. 7, 2026
Hera Women's Health is highlighting results from the PRIME multicenter randomized controlled trial sponsored by Sera Prognostics, Inc., with Brian K. Iriye, MD (Hera Women's Health) serving as the study's Primary Investigator and lead author.
LAS VEGAS, Jan. 7, 2026 /PRNewswire-PRWeb/ -- Hera Women's Health is highlighting results from the PRIME multicenter randomized controlled trial sponsored by Sera Prognostics, Inc., with Brian K. Iriye, MD (Hera Women's Health) serving as the study's Primary Investigator and lead author.
PRIME evaluated whether identifying otherwise "hidden" risk for spontaneous preterm birth using a mid–second-trimester maternal blood biomarker test (IGFBP4/SHBG) and then applying a targeted care pathway could improve outcomes in pregnancies considered low risk overall. Higher-risk patients in the screen-guided arm were offered a bundle including vaginal progesterone, low-dose aspirin, and weekly telephonic nurse care management.
Hera views preterm birth as an avoidable high-risk event in many cases: a complication that can often be anticipated earlier, managed proactively, and measured by outcomes that matter to families, health systems, and insurers—especially NICU admissions and neonatal morbidity. PRIME supports that approach by showing that a proactive, standardized pathway can make a measurable difference.
PRIME was a large 19-site randomized controlled trial of 5018 participants in both university and community practice settings. Compared with routine care, the screen-guided approach was associated with:
- 20% reduction in the composite neonatal morbidity/mortality index (OR 0.80; p = 0.015).
- Shorter neonatal hospital length of stay (IRR 0.95; p = 0.004).
- Fewer NICU admissions (10.2% vs 12.8%; OR 0.78; p = 0.006), with 58 fewer NICU admissions and 545 fewer NICU days in the screen-guided arm.
"PRIME shows that when we identify risk earlier with a biomarker and then act with a consistent, scalable pathway, we can reduce NICU admissions and improve neonatal outcomes," said Brian K. Iriye, MD, Primary Investigator. "That is exactly the type of proactive, outcomes-driven maternity care that only Hera is working on to operationalize at scale."
Large womens' healthcare platforms emphasize enabling broad networks and practice infrastructure. Newer boutique startups are innovating on easily reproduced access and patient experience models with little scientific evidence of true care improvements.
"Preterm birth is one of the most impactful events we can work to prevent," said Andy Wagner, CEO, Hera Women's Health. "PRIME reinforces Hera's focus on earlier detection, standardized care pathways, and measurable outcomes—so we can reduce avoidable neonatal harm and help families start healthier."
Hera's distinction is combining the reach of a major women's healthcare provider with physician-led evidence generation and outcomes-based maternity pathways—with PRIME serving as peer-reviewed, randomized-trial support for treating preterm birth risk as something that can be identified earlier and addressed proactively. This is one of the many ways Hera Womens Health is achieving 25% reductions in preterm birth and 40% reductions in cesarean deliveries when compared to other regional competitors.
Study: Neonatal impact of maternal biomarker screening for risk of preterm birth with targeted interventions (PRIME): A multicenter, randomized, controlled trial.
https://obgyn.onlinelibrary.wiley.com/doi/10.1002/pmf2.70202
About Hera Women's Health
Hera Women's Health is a national collaborative of leading women's health practices dedicated to providing advanced, personalized care for women at every stage of life. The company sets the standard for data-driven, outcome-oriented care and supports the growth and performance of women's health practices across the country. Hera is focused on driving value by facilitating collaboration between Obstetrics and Maternal Fetal Medicine ("MFM") providers and administrators through proprietary evidence-based protocols, technology, and biomedicine. The company is committed to developing and enhancing evidence-based clinical protocols, collaborating with partners across the healthcare ecosystem, expanding access to care into maternal deserts, and improving healthcare outcomes.
Media Contact
Mike McCleney, Hera Women's Health, 1 (617) 543-3444, MMcCleney@hera-health.com, https://hera-health.com
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