Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06284421

Durometer for Measuring Uterine Tone

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Uterine Tone Disorders Cesarean Section Complications

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. feasibility of a durometer

    Time frame: 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 outcomes

  1. durometer reading

    Time frame: 0 minutes after placental delivery

    average durometer reading at lower uterine segment and fundus

  2. durometer reading

    Time frame: 3 minutes after placental delivery

    average durometer reading at lower uterine segment and fundus

  3. durometer reading

    Time frame: 10 minutes after placental delivery

    average durometer reading at lower uterine segment and fundus

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

    Time frame: 0 minutes after placental delivery

    correlation of 2 measures

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

    Time frame: 3 minutes after placental delivery

    correlation of 2 measures

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

    Time frame: 10 minutes after placental delivery

    correlation of 2 measures

Study contacts

Contact information is provided by the study sponsor or research team.

Al McAuley

CONTACT

[email protected]

(773) 834-3274

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Use of a Durometer to Measure Uterine Tone in Cesarean Delivery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.