Cesarean Section Complications, Uterine Tone Disorders
Conditions
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.
Interventions
DEVICEShore durometer
The durometer will be held on the exterior of the lower uterine segment and fundus to measure the hardness reading at each location.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of a durometer | 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
| Measure | Time frame | Description |
|---|---|---|
| durometer reading | 0 minutes after placental delivery | average durometer reading at lower uterine segment and fundus |
| 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 2 measures |
Countries
United States
Contacts
Primary ContactAl McAuley
Outcome results
None listed