Durometer for Measuring Uterine Tone

Not Applicable

Recruiting

• Conditions: Uterine Tone Disorders; Cesarean Section Complications
• Interventions: Device: Shore durometer

• Registration Number: NCT06284421
• Lead Sponsor: University of Chicago

Brief 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.

Study Timeline

• Study Start: 2024-02-08
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-03-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center
• Patients ages 18-50

Exclusion Criteria

• Patients undergoing unscheduled (intrapartum) cesarean delivery
• Ages <18 or >50 years old
• Intrapartum cesarean hysterectomy
• Inability to provide independent, informed consent due to impairment or intellectual disability
• Non-English speaking patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durometer	Shore durometer	This is a single-arm trial in which a Shore durometer will be used to measure the hardness of the uterus after placental delivery during cesarean section.

Primary Outcome Measures

Name	Time	Method
feasibility of a durometer	within 10 minutes after placental delivery	The primary outcome will be the ability to obtain reliable readings of the 'hardness' of the uterus during a cesarean delivery.

Secondary Outcome Measures

Name	Time	Method
durometer reading	10 minutes after placental delivery	average durometer reading at lower uterine segment and fundus
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")	10 minutes after placental delivery	correlation of 2 measures

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States