# Labor Status Monitor for diagnosing True versus False Labor in preterm patients

> **NIH NIH R44** · PRETEL, INC. · 2022 · $1,375,524

## Abstract

Pregnant women often experience preterm uterine contractions, but current methods of evaluation
cannot quickly and accurately diagnose True Labor versus False Labor. Currently, these evaluations for
“threatened labor” average 4 hours, and too frequently the resulting diagnosis is incorrect. Incorrect diagnoses
lead to failure to administer therapies that prevent complications of prematurity or lead to lengthy, expensive
and needless hospitalizations. Long evaluations create inefficiencies and delays starting proven therapies.
Deliveries due to preterm labor are responsible for $10 B in annual healthcare costs in the US.
 Current methods produce many false positive and false negative diagnoses. Current methods diagnose
True Labor in preterm patients with a sensitivity of only 40-60% and specificity of 60-85%. Each false negative
result is a missed opportunity to treat with steroids before birth. Missing steroids increases the risk of lung and
brain complications for premature babies. Each false positive is an inappropriate admission and treatment.
 The need to diagnose labor status more rapidly and accurately has been recognized for decades, but
previous attempts have yielded only modest gains. PreTeL’s Labor Status Monitor provides major
improvements using a revolutionary technological approach. This new approach arose from new knowledge of
how the human uterus creates contractions, and then discovering how to determine if individual contractions
are strong or weak. The core technology (uterine EMG) is well-established, but three key innovations are
added. First, directional EMG sensors, called Area Sensors, are used to localize signals that originate on the
uterine wall; Second, the local contractions are analyzed based on the degree of synchronization, or timing of
the signals at different locations on the uterus; Third, Area Sensors revealed a unique EMG signal that occurs
between contractions and characterizes False Labor. True versus False Labor is diagnosed based on two
indices, one index for synchronization and the other for the False Labor signals.
 The Labor Status Monitor is designed to diagnose both True Labor and False Labor after only 1 hour of
evaluation and with a higher sensitivity and specificity than current methods. In Aim 1 of this Phase II
application, a clinical trial produces training data that identifies the thresholds of the two indices that optimize
the diagnostic performance of the Labor Status Monitor. In Aim 2, indices are validated. Shortening the time
needed for evaluation by 1 hour and improving sensitivity and specificity by 10% will reduce annual health care
costs by $663 M. This proposal will provide data to fully plan the pivotal trial to support FDA approval.

## Key facts

- **NIH application ID:** 10484554
- **Project number:** 1R44HD109107-01
- **Recipient organization:** PRETEL, INC.
- **Principal Investigator:** ROGER C. YOUNG
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,375,524
- **Award type:** 1
- **Project period:** 2022-09-26 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484554

## Citation

> US National Institutes of Health, RePORTER application 10484554, Labor Status Monitor for diagnosing True versus False Labor in preterm patients (1R44HD109107-01). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10484554. Licensed CC0.

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