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Detection of Preterm Birth Risk: A Breakthrough at FIU

In a significant stride for maternal health, biomedical engineers at Florida International University (FIU) have engineered a state-of-the-art imaging device capable of detecting early signs of preterm labor in just five seconds. This groundbreaking technology, named PPRIM (Portable Preterm Imaging), can identify risk up to three months earlier than conventional screening methods. This advancement comes at a critical time when preterm birth rates globally are on the rise, causing a mother to face immense anxiety and concern about the health of their unborn child.

Every 40 seconds, a baby succumbs to complications arising from preterm birth, accumulating to more than 2,000 infants lost daily. Despite the urgency and gravity of this issue, healthcare providers have been limited in their ability to predict accurately which pregnancies are the most precarious. Preterm births, defined as deliveries before 37 weeks of gestation, expose infants to increased dangers of developmental challenges, respiratory issues, and brain injuries.

Jessica Ramella-Roman, a professor of biomedical engineering at FIU, has been developing this innovative technology in the university’s Medical Photonics Lab for over a decade. She emphasized, “There aren’t many tools that can monitor this hidden process, and the ones we currently have fall short in effectiveness.” Traditional screening techniques, like manual physical cervix examinations, often miss about 70% of at-risk pregnancies. Other methods, including lab tests that check protein levels, only deliver insights late in the pregnancy, while the existing ultrasound approach merely measures cervix length, without evaluating risk factors directly.

Understanding the cervix's role during pregnancy is crucial; during a healthy term, the cervix secures the baby, with collagen fibers positioned in an orderly alignment akin to rope strands. As the pregnancy reaches its conclusion, these fibers undergo natural disorganization, whereas in preterm births, this breakdown process initiates prematurely. PPRIM combats these diagnostic coverage gaps by utilizing specialized polarized light directed onto the cervix, capturing detailed images of collagen fiber arrangements. The device’s bespoke software translates these images into a color-coded risk map, where cooler colors indicate organized fibers signifying a lesser risk, while warmer colors represent disorganized fibers that heighten risk levels.

A pivotal pilot study conducted at Jackson Health, published in the Journal of Biomedical Optics, validated that disorganization in tissue structure serves as an early warning signal. PPRIM originally began with a cumbersome colposcope, a magnification instrument commonly used for cervical examinations. However, through years of refinement and numerous patents, the solution has been condensed into a sleek, portable handheld device.

The guiding forces behind PolarDoc, the startup commercializing PPRIM, are FIU doctoral students Jenny Pei and Amanda Sanchez. Thanks to the National Science Foundation’s Innovation Corps (NSF I-Corps) entrepreneurship program, the duo extensively engaged with nearly 100 participants, including physicians, nursing professionals, mothers, and insurance providers, uncovering a robust demand for their revolutionary tool. This engagement also led them to the finals of the prestigious Hult Prize competition.

Pei described the technology’s impact by stating, “Rather than simply reacting to preterm labor once it starts, physicians could proactively anticipate and take steps to prevent it. We believe this proactive approach can save lives.” As they look forward, Pei and her team collaborate with Baptist Health South Florida for a forthcoming clinical trial focused on pregnant women, under the guidance of Dr. Larry Spiegelman, medical director of Women’s Services at Baptist Hospital and clinical assistant professor at FIU’s Herbert Wertheim College of Medicine. The trial’s data will aid in the FDA approval process for PPRIM.

Moreover, researchers are also considering the potential for adapting this technology to enhance cervical cancer screening. Dr. Spiegelman shared, “While cervical insufficiency represents a smaller percentage of preterm births, mitigating even a single premature delivery can have a monumental impact—on the patient, their family, and our healthcare system as a whole.” Depending on the outcome of the clinical trials, PPRIM could give clinicians a minimally invasive method to identify risks sooner, enabling them to intervene effectively—like implementing a cervical cerclage, extending pregnancy durations, and administering crucial medications to safeguard a baby’s lung and brain development.

The implications of this technology are immense, potentially redefining how healthcare approaches pregnancy management and preterm labor prevention. The collaborative efforts of FIU's research teams hold promise not only for expectant mothers but the broader healthcare landscape as well, heralding a new era in prenatal care.