Clinical trial NCT06284421: Durometer for Measuring Uterine Tone
Official title: Use of a Durometer to Measure Uterine Tone in Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Tone Disorders
Cesarean Section Complications
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

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

Primary outcomes:
measure: feasibility of a durometer
timeFrame: within 10 minutes after placental delivery
Secondary outcomes:
measure: durometer reading
timeFrame: 0 minutes after placental delivery
measure: durometer reading
timeFrame: 3 minutes after placental delivery
measure: durometer reading
timeFrame: 10 minutes after placental delivery
measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
timeFrame: 0 minutes after placental delivery
measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
timeFrame: 3 minutes after placental delivery
measure: correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
timeFrame: 10 minutes after placental delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Naida Cole, MD
role: PRINCIPAL_INVESTIGATOR
References: