Over 85% of women suffer obstetric trauma to one or several components of the pelvic floor, with vagina, perineal body, levator ani muscles, and the anal sphincter complex affected most commonly. Birth injury to these integral structural components of the female pelvic floor leads to pelvic pain and dyspareunia, and serves as the most important and potentially modifiable risk factor for subsequent pelvic floor disorders. Unfortunately, there are currently no preventive strategies beyond elective Cesarean delivery, which is associated with many untoward consequences. Our central thesis that pelvic tissues? biomechanical properties in late pregnancy determine the risk of birth injury for a set of specific intrapartum conditions, i.e. fetal head size, shape/size of maternal bony pelvis, duration of expulsive efforts. The long-term goal of this project to develop, validate and integrate into clinical practice a novel device, Antepartum Tactile Imager (ATI), to simultaneously measure biomechanical properties of various pelvic structural components that are impacted during vaginal delivery, and to develop a risk prediction model of maternal birth injury by correlating ATI data with postpartum outcomes. Ultimately, such model will enable individualized patient counseling regarding the mode of delivery and/or the need for obstetrical interventions to reduce childbirth trauma. Phase I Specific Aims target to design ATI ?-prototype and explore imaging quality, examination technique, probe design and safety in a pilot clinical study of non-pregnant and pregnant women.

Public Health Relevance

Over 85% of women suffer some degree of perineal trauma during a vaginal delivery. Cesarean delivery itself is a trauma with immediate and long term consequences. The long-term goal of this project to develop, validate and integrate into clinical practice a novel device, Antepartum Tactile Imager (ATI), to simultaneously measure biomechanical properties of various pelvic structural components that are impacted during vaginal delivery, and to develop a risk prediction model of maternal birth injury by correlating ATI data with delivery outcomes. Ultimately, such model will enable individualized patient counseling regarding the mode of delivery and/or the need for obstetrical interventions to reduce childbirth trauma.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD095223-01
Application #
9517632
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Miodovnik, Menachem
Project Start
2018-04-03
Project End
2019-03-31
Budget Start
2018-04-03
Budget End
2019-03-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Advanced Tactile Imaging, Inc.
Department
Type
DUNS #
078793844
City
Trenton
State
NJ
Country
United States
Zip Code