# Fully Quantitative Cervical Elastography for Prediction of Preterm Birth in Nulliparous Patients

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $689,431

## Abstract

ABSTRACT
An estimated 13 million preterm births (PTBs) occur annually worldwide and PTB is the single most significant
contributing factor to neonatal morbidity and mortality. The inability to correctly identify patients at risk for PTB
limits efficient research progress by preventing assembly of cohorts actually at risk for the disease and leaves
major research investments with heterogenous cohorts, modest or conflicting effects of interventions tested, and
unclear clinical translation. Current PTB prediction is applied according to two primary risk factors: 1) prior PTB
and 2) short cervical length on ultrasound. These two risk criteria are particularly problematic in nulliparous
patients because they have no obstetric history to guide risk stratification, and cervical length has poor predictive
ability. In fact, in a 2021 American College of Obstetrics and Gynecology practice bulletin on PTB prevention,
the authors concluded that “whether and how to screen nulliparous women is a matter of uncertainty and debate.”
Cervical tissue elastography is a promising technique to measure cervical remodeling. However, current systems
are unable to quantify the pressure applied to the cervix, making the measurement non-quantitative and thereby
preventing standardization between examiners, longitudinal within-patient comparisons, and between-patient
comparisons. We have overcome this key limitation with a novel, precise, operator-independent, ultrasound-
based imaging modality—fully quantitative cervical elastography system (Q-CES). Our preliminary data
shows that 1) cervical stiffness, detectable by Q-CES in early pregnancy, is significantly associated with
spontaneous PTB, and 2) Q-CES may have stronger predictive utility for spontaneous PTB than cervical length.
The aims of this proposal will test the overall hypothesis that Q-CES values of cervical stiffness can more
accurately predict spontaneous PTB than cervical length using a multicenter, diverse prospective cohort. In Aim
1 we will, for the first time, quantify normative Q-CES values of cervical stiffness in nulliparous patients who
deliver at term versus preterm. In Aim 2 we will use Q-CES to develop a multiparametric risk prediction model
for spontaneous PTB compared to existing models based on cervical length.
We have an established, multidisciplinary team already performing Q-CES at all three centers in this proposal,
with equipment in place and ready to be leveraged for this project. We will enroll 35% Black and Hispanic patients
to ensure that our results can explore the persistent racial and ethnic disparities in PTB risk. Completion of these
aims will allow us to, for the first time, numerically quantify cervical tissue stiffness longitudinally in pregnancy
and to detect softening patterns predictive of spontaneous PTB. This will be directly clinically actionable and
address a fundamental roadblock in PTB science by improving the ability to assemble rational research cohorts
for more meanin...

## Key facts

- **NIH application ID:** 10906749
- **Project number:** 5R01HD109251-02
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Molly Stout
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $689,431
- **Award type:** 5
- **Project period:** 2023-08-14 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10906749

## Citation

> US National Institutes of Health, RePORTER application 10906749, Fully Quantitative Cervical Elastography for Prediction of Preterm Birth in Nulliparous Patients (5R01HD109251-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10906749. Licensed CC0.

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