Durometer for Measuring Uterine Tone

NCT06284421 | Recruiting FDA Device

• 1 other identifier: IRB23-1068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Tone Disorders; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• durometer reading

  0 minutes after placental delivery

• durometer reading

  3 minutes after placental delivery

• durometer reading

  10 minutes after placental delivery

• correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")

  0 minutes after placental delivery

• correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")

  3 minutes after placental delivery

Study Arms (1)

Durometer

EXPERIMENTAL

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.

Device: Shore durometer

Interventions

Shore durometer DEVICE

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

Durometer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Study Officials

• Naida Cole, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Al McAuley

CONTACT

(773) 834-3274; amcauley1@dacc.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To determine the feasibility of using a portable, digital Shore OO durometer to measure uterine tone during elective cesarean delivery. We hypothesize that this durometer will be easy to use by operating obstetricians for the measurement of uterine tone during cesarean delivery. Also we hope to be to correlate the hardness of uterine tone, as measured by the Shore OO durometer, with a 0-10 score on the uterine tone score and the administration of extra uterotonic drugs for uterine atony. \[NB- the administration of extra uterotonic drugs is dependent on the clinical decision made by the obstetrician in agreement with the anesthesiologist.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 29, 2024
• Study Start: February 8, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)