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This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| durometer reading | average durometer reading at lower uterine segment and fundus | 0 minutes after placental delivery |
| durometer reading | average durometer reading at lower uterine segment and fundus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Al McAuley | Contact | (773) 834-3274 | amcauley1@dacc.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Naida Cole, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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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.](streamdown:incomplete-link)
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| 3 minutes after placental delivery |
| durometer reading | average durometer reading at lower uterine segment and fundus | 10 minutes after placental delivery |
| 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 |
| 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 |
| 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 |