NCT06284421

Durometer for Measuring Uterine Tone

Use of a Durometer to Measure Uterine Tone in Cesarean Delivery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.

Detailed description

The most accurate and precise measure of uterine tone is unknown. The most commonly described in vivo method in the literature is a qualitative numeric scoring scale from 0-10. The 0-10 uterine tone score has demonstrated good and excellent inter-rater reliability between 1 and 2 raters respectively, and good inter-rater agreement. Recent data suggests that the 0-10 uterine tone score is well-correlated with clinical assessments of uterine tone. A handful of studies have used a quantitative "hardness meter", including a Shore durometer, to describe uterine tone in vivo, with promising results. The instrument has not yet been validated in cesarean delivery.

Conditions

• Uterine Tone Disorders
• Cesarean Section Complications

Interventions

Type	Name	Description
DEVICE	Shore durometer	The durometer will be held on the exterior of the lower uterine segment and fundus to measure the hardness reading at each location.

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-03-30
• Completion: 2026-08-30
• First posted: 2024-02-29
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study