Durometer for Measuring Uterine Tone

Cesarean Section Complications Clinical Trial

Official title:

Use of a Durometer to Measure Uterine Tone in Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284421
• Other study ID #: IRB23-1068
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: University of Chicago
• Contact: Al McAuley
• Phone: (773) 834-3274
• Email: amcauley1[@]dacc.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Uterine Tone Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of a durometer	The primary outcome will be the ability to obtain reliable readings of the 'hardness' of the uterus during a cesarean delivery.	within 10 minutes after placental delivery
Secondary	durometer reading	average durometer reading at lower uterine segment and fundus	0 minutes after placental delivery
Secondary	durometer reading	average durometer reading at lower uterine segment and fundus	3 minutes after placental delivery
Secondary	durometer reading	average durometer reading at lower uterine segment and fundus	10 minutes after placental delivery
Secondary	correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")	correlation of 2 measures	0 minutes after placental delivery
Secondary	correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")	correlation of 2 measures	3 minutes after placental delivery
Secondary	correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")	correlation of 2 measures	10 minutes after placental delivery