Durometer for Measuring Uterine Tone

The University of Chicago

Status: Enrolling

Conditions: Cesarean Section Complications; Uterine Tone Disorders

Treatments: Device: Shore durometer

Study type: Interventional

Funder types: Other

Identifiers

NCT06284421

IRB23-1068

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Durometer

Experimental group

Description:

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.

Treatment:

Device: Shore durometer