Preterm delivery is a leading cause of infant mortality and morbidity. It is estimated that annually about 15 million infants are born preterm. Across 184 countries, the rate of preterm birth ranges from 5% to 18%. In most countries, the rate of preterm birth has risen in the recent decades, and now preterm birth represents the most common cause of neonatal mortality. It is the second largest direct cause of death in children up to 5 years of age. Most preterm births occur spontaneously. Therefore, identifying women at risk for spontaneous preterm delivery (SPTD) remains an issue of paramount importance. Premature softening, shortening and dilation of the cervix, which may be considered as its early mechanical failure, is associated with the preterm birth. Recent clinical findings confirm the hypothesis that cervical elastography may provide effective biomarkers to predict preterm delivery. However, in the current clinical practice, the progress of the cervix ripening is often monitored subjectively by visual inspection and digital examination. Even though numerous risk factors associated with SPTD have been identified in the previous decades, the ability to accurately predict when labor will occur remains elusive. The discovery and validation of new biomarkers; their combination with complementary markers and the known risk factors could help identify the conditions leading to SPTD. In the Phase I research, a pilot clinical study with 10 non-pregnant and 10 pregnant women has demonstrated satisfactory measurement performance and reproducibility of the ?-prototype of the Cervix Monitor (CM) based on the acquisition of stress-strain data by tactile and ultrasound transducers. Availability of stress-strain data allowed computation of cervix elasticity and length. The main goal of Phase II is to conduct extensive clinical studies to collect quantitative data on the cervix at the end of the second trimester of pregnancy with updated ?-prototype CM device. It will include a development (pre-validation) and clinical validation studies to test the hypotheses about the CM predictive capability for SPTD. The long-term objective of the project is to bring into clinical practice a compact, cost-effective and easy-to-use device for measurement of cervix elasticity, length, and assessing the risk of SPTD.
Public Health Relevance Statement: PROJECT NARRATIVE Preterm delivery is a leading cause of infant mortality and morbidity. It is estimated that annually about 15 million infants are born preterm. Across 184 countries, the rate of preterm birth ranges from 5% to 18%. It is the second largest direct cause of death in children up to 5 years of age. Most preterm births occur spontaneously. Therefore, identifying women at risk for spontaneous preterm delivery remains an issue of paramount importance. The discovery and validation of new biomarkers; their combination with complementary markers and the known risk factors could help identify the conditions leading to preterm birth. This project aims development of a Cervix Monitor based on the acquisition of stress-strain data by tactile and ultrasound transducers. Availability of stress-strain data allowed computation of cervix elasticity and length. The long-term objective of the project is to bring into clinical practice a compact, cost-effective and easy-to-use device for predicting of spontaneous preterm delivery.
Project Terms: 5 year old; Algorithmic Software; base; Biological Markers; biomaterial compatibility; Breast; Cause of Death; Certification; Cervical; Cervix Uteri; Child; Clinical; clinical development; clinical practice; Clinical Research; Computer software; cost effective; Country; Coupling; Data; design; Development; Devices; diagnostic accuracy; digital; Effectiveness; Elasticity; elastography; Electromagnetics; Failure; Female; Goals; Grant; Imaging Device; imaging system; Imaging technology; Infant; infant morbidity; Infant Mortality; interest; Legal patent; Length; Measurement; Mechanics; Modulus; Monitor; monitoring device; Muscle; Neonatal Mortality; off-patent; Outcome; Pelvic floor structure; Performance; Phase; Pregnancy; Pregnant Women; premature; Premature Birth; Procedures; Prostate; prototype; Reporting; Reproducibility; Research; Risk; Risk Assessment; Risk Factors; Safety; Second Pregnancy Trimester; Secure; sensor; Software Design; software development; Stress; System; Tactile; Test Result; Testing; Time; TimeLine; transmission process; Ultrasonic Transducer; Ultrasonography; United States National Institutes of Health; Update; usability; Vagina; Validation; validation studies; Visual; Wireless Technology; Woman
