# Cervix monitor for risk assessment of spontaneous preterm delivery

> **NIH NIH R44** · ADVANCED TACTILE IMAGING, INC. · 2020 · $694,202

## Abstract

PROJECT SUMMARY
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 α-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
β-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.

## Key facts

- **NIH application ID:** 9902476
- **Project number:** 5R44HD090793-03
- **Recipient organization:** ADVANCED TACTILE IMAGING, INC.
- **Principal Investigator:** Vladimir Egorov
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $694,202
- **Award type:** 5
- **Project period:** 2016-09-22 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9902476

## Citation

> US National Institutes of Health, RePORTER application 9902476, Cervix monitor for risk assessment of spontaneous preterm delivery (5R44HD090793-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9902476. Licensed CC0.

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