Cervix monitor for risk assessment of spontaneous preterm delivery

Project Summary Preterm birth is a leading cause of infant mortality and morbidity, with an estimated 13.4 million babies born preterm in 2020. The rate of preterm birth varies across countries, ranging from 4% to 16%. Notably, preterm birth now represents the leading cause of death among children under 5 years of age. Preterm birth ranks among the most complex and pressing challenges in obstetrics. Most preterm births occur spontaneously, making the identification of women at risk for spontaneous preterm birth (sPTB) a paramount issue. Premature softening, shortening, and dilation of the cervix, which may be considered early mechanical failure, is associated with preterm birth. Clinical findings support the hypothesis that cervical elastography may provide effective biomarkers for predicting preterm delivery. However, in current clinical practice, the progress of cervical ripening is often monitored subjectively through visual inspection and digital examination. The digital cervical score and Bishop score, while used as predictors of sPTB, show relatively low diagnostic accuracy, ranging from 61% to 68%. Despite numerous risk factors associated with sPTB having been identified in previous decades, the ability to accurately predict when spontaneous labor will occur remains elusive. That is why the validation of novel biomarkers, which could identify conditions leading to sPTB with a high level of confidence, is so important. In Phases I and II of the research, a novel, cost-effective technique was developed and tested in feasibility and development clinical studies. Receiver operating characteristic analysis revealed that cervical elasticity, expressed as the stress-to-strain ratio, had 95.0% accuracy (95% CI, 88.5–100.0) for predicting sPTB. The developed probe, integrating four tactile and a single ultrasound transducer, demonstrated potential in predicting sPTB cost-effectively. The primary aim of Phase IIB is to conduct a clinical validation study on 750 pregnant women, collecting data at the end of the second trimester using the updated pre-production Cervix Monitor device. This data will facilitate two separate FDA submissions: one for a measurement claim and another for a diagnostic claim. The overarching objective of this project is to introduce a compact, cost-effective, and user- friendly device into clinical practice, designed for the detection of conditions leading to sPTB.