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NCT06284421 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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