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Durometer for Cesarean Section Complications

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes after placental delivery

Awards & highlights

Study 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 below

Select...

I am between 18 and 50 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes after placental delivery for reporting.

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,757 Total Patients Enrolled

Naida Cole, MDPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

142 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a participant in this clinical trial?

"Individuals eligible for this study must have uterine tonal irregularities and fall within the age bracket of 18 to 50. A total of 20 participants will be accepted into the trial."

Answered by AI

Are researchers currently enrolling participants for this study?

"Yes, data from clinicaltrials.gov indicates that this trial is actively seeking volunteers. The initial posting date was 2/8/2024 with the latest update on 2/27/2024. Enrollment aims to include 20 participants at a single site."

Answered by AI

How many individuals are enrolled as participants in this ongoing medical study?

"Indeed, the current data on clinicaltrials.gov indicates that this research project is actively seeking volunteers. Initially shared on February 8th, 2024, and last revised on February 27th, 2024, the study aims to enroll a total of 20 participants from one designated site."

Answered by AI

Is the trial open to participants younger than 55 years of age?

"Eligibility for this research demands participants to be between the ages of 18 and 50. Please note that there is one trial specifically catering to individuals under 18 years old, while ten trials are designated for those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durometer for Measuring Uterine Tone

2024. "Durometer for Measuring Uterine Tone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06284421.

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