helping mother and child by predicting the timing of delivery and outcomes for preterm and term birth
This innovation is funded for a second year by the Frankel Innovation Initiative, a $20 million fund made possible by a generous donation from the Maxine and Stuart Frankel Foundation that supports the research and development of life-saving therapies at Michigan Medicine. This project was renewed based on the successful completion of the Year 1 milestones and the Year 2 milestones proposed.
Preterm (also known as premature) birth is when a baby is born too early, before the 37th week of pregnancy. Over 10 percent of babies in the United States are born preterm (PTB), putting them at immediate risk of death and lifelong adverse health outcomes. Battling PTB faces many challenges, such as poor prediction, limited prevention, and high morbidity.
A multi-disciplinary, multi-institutional team of obstetric physician-scientists, engineers, imaging and statistical experts, and clinical research staff have developed a precise, non-invasive imaging method—quantitative cervical elastography—to monitor cervical remodeling, the process by which the cervix shortens, softens, and dilates to allow passage of the fetus. Led by University of Michigan’s Molly Stout, M.D., M.S.C.I., the team is modifying the standard transvaginal ultrasound probe in order to determine the stiffness (Young’s modulus) of the cervix, thereby predicting the time of delivery and risk of PTB.
Dr. Peinan Zhao, Ph.D., from Washington University in St. Louis, developed the image processing and analytical approach for this device. “Our technology is aimed at monitoring cervical remodeling, the required step that precedes both preterm and term birth,” says Dr. Zhao.
“We are confident that the wide clinical applications of this robust scientific data will make us uniquely poised to measure what, to date, has been unmeasurable: the cervical biology that precedes labor,” comments Dr. Stout. “Additionally, expanding the use of our device to monitor term pregnancy provides huge expansion of clinical use opportunities and proportionate commercialization value.”
Methodius Tuuli, M.D., M.P.H., M.B.A., from Brown University, also expresses excitement for the innovative device: “We have the opportunity to close critical knowledge gaps in obstetric disease.”
The first year of Frankel Innovation Initiative funding allowed for testing of the device to predict PTB outcomes, which resulted in the development of norms for normal and abnormal cervical ripening patterns and the ability to predict PTB within seven days of accuracy. Funding in the second year will expand the use beyond preterm birth and into term births to detect the opposite end of abnormal cervical remodeling: delayed or absent cervical remodeling, leading to abnormally prolonged pregnancy.
PTB is a major contributor to neonatal death and morbidity, complicates more than 10 percent of the nearly four million annual births in the United States, and costs over $26 billion annually. Despite the high burden of disease and significant costs, meaningful progress is hampered by the inability to predict, with accuracy, when labor will occur.
The device is a fully quantitative cervical elastography probe that is based on a modified standard transvaginal ultrasound probe. It can simultaneously quantify pressure and deformation to fully measure Young’s modulus (the stiffness) of cervical tissue, which calculates the stress and strain ratio to assess tissue elastography and predict labor.
The device will improve the prediction of preterm and term birth, allowing more accurate targeting of critical inventions to optimize maternal and neonatal outcomes. Current methods to assess cervical remodeling have significant limitations, including a digital assessment of cervical stiffness that is non-quantitative, strategies prone to examiner differences, and ultrasound measurement of cervical length with poor predictive value. Alternative strategies that have been explored include relative elastography, reference elastography, and shear wave elastography, none of which provide the prediction strength and promise of the fully quantitative cervical elastography probe.
- Intellectual Property: Intellectual property applications to be filed for hardware and software image processing.
- Commercialization Strategy: Integration of term labor outcomes in year two broadens the use of this device across the obstetric spectrum and greatly expands the diversity of clinical applications for quantitative cervical elastography.
- Regulatory Pathway: Device may be incorporated into an acquiring manufacturer’s transvaginal ultrasound device and regulated under that product code as a 501(k)-clearance.
- Engage Investors: Cervical elastography characteristics will be compared to standard cervical length imaging to prove that cervical elastography provides improved prediction over current methodologies in order to generate enthusiasm by payers, commercial companies, and societies that generate obstetric care guidelines.
- Product Launch Strategy: Leveraging transvaginal ultrasound ensures that findings will be easily translated into clinical obstetric imaging units.
- Completion of imaging and analysis for preterm birth focused aims proposed in Year 1 of Frankel Innovation Initiative Funding.
- Longitudinal cervical elastography imaging over pregnancy in asymptomatic patients to define normal and abnormal cervical ripening processes throughout pregnancy that predict preterm birth.
- Cervical elastography imaging in symptomatic patients presenting to the obstetric triage area with complaints of preterm labor