Actively Recruiting
Use of a Durometer to Measure Uterine Tone in Cesarean Delivery
Led by University of Chicago · Updated on 2025-05-06
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a Shore durometer, a device that measures hardness, to assess uterine tone in women undergoing cesarean delivery. The study aims to find a more accurate and precise way to measure uterine tone, which is currently assessed using a qualitative 0-10 numeric scale. This device has shown promising results in previous studies but has not yet been validated specifically during cesarean delivery. In this single-arm trial, the Shore durometer will be used to measure the hardness of the uterus after the placenta is delivered during cesarean section. Measurements will be taken at the lower uterine segment and fundus immediately after placental delivery, and then again at 3 and 10 minutes post-delivery. The study will compare these durometer readings with the traditional 0-10 uterine tone score to evaluate correlation and feasibility. Participants will undergo scheduled cesarean delivery at the University of Chicago Family Birth Center. The durometer measurements will be taken within 10 minutes after placental delivery to assess feasibility. Researchers will monitor the durometer readings at specified time points and compare them with clinical uterine tone scores. The total participation involves the cesarean procedure and the immediate post-delivery measurement period, focusing on the device's performance and reliability.
CONDITIONS
Brief Title
Durometer for Measuring Uterine Tone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled (non-emergency) cesarean delivery at University of Chicago Family Birth Center
- Female patients aged 18 to 50 years
You will not qualify if you...
- Unscheduled (intrapartum) cesarean delivery
- Age younger than 18 or older than 50 years
- Intrapartum cesarean hysterectomy
- Unable to provide independent, informed consent due to impairment or intellectual disability
- Non-English speaking patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At time of cesarean delivery
Participants undergo a scheduled cesarean delivery during which a Shore durometer is used to measure uterine hardness at the lower uterine segment and fundus after placental delivery.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
A
Al McAuley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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