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Durometer for Uterine Tone During Cesarean Section
N/A
Recruiting
Led By Naida Cole, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients ages 18-50
Be between 18 and 65 years old
Must not have
Inability to provide independent, informed consent due to impairment or intellectual disability
Ages <18 or >50 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes after placental delivery
Awards & highlights
Summary
This trial aims to use a device called a durometer to measure the strength of the uterus in women having a cesarean delivery.
Who is the study for?
This clinical trial is for women undergoing cesarean delivery who may have uterine tone disorders. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements.Check my eligibility
What is being tested?
The trial is testing a device called a Shore durometer to measure the firmness of the uterus (uterine tone) in patients having a cesarean section. The goal is to see how well this tool works in a real-world medical setting.See study design
What are the potential side effects?
Since this trial involves measuring with a durometer rather than medication or invasive procedures, significant side effects are not expected. However, any discomfort or potential risks will be clarified by the research team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot give consent on my own due to a mental or intellectual condition.
Select...
I am either younger than 18 or older than 50.
Select...
I had a hysterectomy at the same time as my cesarean delivery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes after placental delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes after placental delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
feasibility of a durometer
Secondary outcome measures
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
durometer reading
Trial Design
1Treatment groups
Experimental Treatment
Group I: DurometerExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shore durometer
2019
N/A
~30
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,018 Previous Clinical Trials
734,595 Total Patients Enrolled
Naida Cole, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
142 Total Patients Enrolled
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