December 28, 2021
PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-21-221 - NICHD Small Research Grant Program (R03 Clinical Trial Required)
PA-21-259 - PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PA-21-262 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
PA-21-260 - PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
PA-21-261 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Background
External fetal monitoring (EFM), specifically continuous cardiotocography, was introduced in the early 1960s and considered the intervention that would reduce cerebral palsy and perinatal death. Continuous cardiotocography (cCTG), which provides a continuous record of the fetal heart rate, was adopted with little evidence of its efficacy, and is currently utilized in over 90% of labors, regardless of the risk status of the pregnancy. Consistent evidence gained over the last 60 years demonstrates that cCTG does not reduce the rate of fetal acidemia, cerebral palsy, or perinatal death, and that its use increases the risk of cesarean section by over 60%, a clear risk factor for maternal morbidity and mortality. While the exact reason why cCTG use leads to an increased risk of cesarean section is not known, it is likely due to the interplay of altered provider care processes, decreased patient mobility, and the poor predictive value of cCTG. Furthermore, the universal use of cCTG in every labor regardless of medical risk can initiate a cascade effect in which a potentially unnecessary test results in increased labor interventions and ultimately results in cesarean birth.
As cCTG lacks the specificity and sensitivity to accurately diagnose fetal compromise, there is a critical need to improve the accuracy of non-invasive fetal monitoring. Based on current evidence, cCTG has a false positive rate for predicting cerebral palsy of over 99%. In part, this is due to the poor inter-and intra-observer reliability of cCTG interpretation despite attempts to standardize nomenclature and interpretation. Given the limitations of fetal cardiac monitoring, new modalities are needed that directly measure fetal status (e.g., through measurement of fetal blood pH or fetal oxygenation). This will allow for more appropriate use of medical interventions and ideally lead to fewer cesarean sections as well as reduced fetal acidemia, cerebral palsy, and perinatal death.
New fetal monitoring technology could also improve maternal and fetal outcomes by improving care processes during labor. Although wireless cCTG does exist, it is expensive and prone to malfunction; thus, most external fetal monitoring requires a cable that runs from the patient to a bedside machine. This substantially reduces the mobility of a laboring person. Importantly, limited mobility is a considerable shortcoming in the current management of labor, as freedom of movement is associated with decreased pain, improved quality of uterine contractions, expedited fetal descent, and improved maternal-fetal oxygenation. New technology that allows for freedom of movement would be an important improvement in current clinical practice.
Furthermore, although continuous labor support is an intervention known to improve maternal outcomes, cCTG has resulted in altered care processes that reduce the amount of labor support provided by staff; the focus in the birthing room becomes the technology, not the laboring person. The use of cCTG places a time burden on staff as well, as it is challenging to monitor some patients, particularly in cases of obesity, early gestational age, and multiple gestations. Nurses report adjusting the fetal monitor, on average, 15 times in a 12-hour shift, typically spending more than 1 hour per shift adjusting the monitor. Many birthing people also find the abdominal bands that hold the cCTG in place and the frequent adjustments to be uncomfortable and intrusive. New technology will need to be unobtrusive and accurate across body type, gestational age, and gestation number to address these issues.
Research Objectives
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
Application and Submission Information
This notice applies to due dates on or after February 5, 2022 and subsequent receipt dates through May 8, 2024.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
- PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
- PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
- PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
- PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
- PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
- PA-21-221 - NICHD Small Research Grant Program (R03 Clinical Trial Required)
- PA-21-259 - PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
- PA-21-262 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
- PA-21-260 - PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
- PA-21-261 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
- For funding consideration, applicants must include “NOT-HD-21-053” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Scientific/Research Contact(s)
Telephone: 240-204-4605
Email: monica.longo@nih.gov
and Human Services (HHS)
