Durometer for Measuring Uterine Tone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shore durometer.
- Who it may be relevant to
- Registry conditions: Uterine Tone Disorders, Cesarean Section Complications. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a Durometer to Measure Uterine Tone in Cesarean Delivery
Overview
This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.
Detailed 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.
Interventions
- 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.
Primary outcome measures
- feasibility of a durometer [Time frame: within 10 minutes after placental delivery]
Secondary outcome measures (6)
- durometer reading [Time frame: 0 minutes after placental delivery]
- durometer reading [Time frame: 3 minutes after placental delivery]
- durometer reading [Time frame: 10 minutes after placental delivery]
- 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 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 durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") [Time frame: 10 minutes after placental delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- University of Chicago — Chicago
Identifiers
NCT: NCT06284421 · IRB23-1068