The purpose of this Notice of Special Interest (NOSI) is to stimulate adaptation of non-invasive monitoring technologies for use in fetal assessment. The aim of the initiative is to improve accuracy in fetal assessment, leading to improved clinical decision making and, ultimately, improved maternal and fetal outcomes. Research encouraged and supported by this NOSI should focus on direct assessment of fetal status through non-invasive measurement of fetal blood pH, oxygenation, or other direct measures.
The objectives of this NOSI are to advance the accuracy and useability of fetal assessment technology, ultimately resulting in improved maternal and neonatal outcomes and an enhanced birth experience. This initiative also seeks to build on the growing and advancing field of non-invasive physiologic monitoring and sensor technology. Recent innovations have led to the development of multiple new non-invasive monitoring techniques, including technologies that measure blood pH based on exhaled breath, non-invasive monitors of blood pressure, pulse, and pH based on impedance measurement, optical measurement of hemoglobin and oxygen saturation, and microwave technology for non-invasive measurement of blood components, to name only a few. The unique differences between maternal and fetal physiology could allow for these non-invasive technologies to be adapted to the maternal-fetal dyad, leading to more accurate assessment of fetal status during labor.
This NOSI encourages research and development of technologies that include, but are not limited to, technologies that:
- Directly assess fetal status through non-invasive measurement of fetal blood pH, oxygenation, or other direct measures
- Are highly accurate in identifying the at-risk fetus
- Work reliably across gestational age, gestation number, and maternal body type
- Are unobtrusive and comfortable
- Allow for freedom of movement of the laboring person
This notice applies to due dates on or after February 5, 2022 and subsequent receipt dates through May 8, 2024.
NOT-HD-21-053