Durometer for Uterine Tone During Cesarean Section

Overseen By Al McAuley

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Unscheduled cesarean, Age, Consent, Language, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 minutes

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure uterine firmness during a cesarean section. By using a device called a Shore durometer, researchers aim to better understand uterine tone after placenta delivery. The study could improve care during C-sections. Women planning a scheduled C-section at the University of Chicago Family Birth Center who can give informed consent might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance C-section procedures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the durometer is safe for measuring uterine tone during cesarean sections?

Research shows that using a Shore durometer to measure uterine firmness during a cesarean section aims to provide reliable readings. No specific studies have discussed safety issues with the durometer itself. This study is marked as "Not Applicable" for clinical trial phases, indicating a focus on assessing the device's measurement accuracy rather than testing a new drug or invasive treatment. Generally, medical devices like durometers are non-invasive, making them easy to tolerate and posing minimal risk. The main goal is to ensure the device consistently provides accurate measurements without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a Shore durometer during cesarean sections because it offers a new way to measure uterine tone. Unlike traditional methods that rely on subjective assessments by touch, the durometer provides an objective, quantifiable measurement of uterine hardness. This could lead to more precise monitoring and management of uterine tone, potentially improving outcomes for both mothers and babies during and after delivery.

What evidence suggests that using a durometer is effective for measuring uterine tone during cesarean section?

Research shows that checking uterine firmness during a C-section can assist doctors. In this trial, the Shore durometer will measure this firmness. Although limited information exists on the durometer's effectiveness specifically for the uterus, it is designed to provide accurate readings of uterine hardness after childbirth. This could help doctors better understand and manage the uterus's condition during the procedure. Other tools measuring uterine firmness have proven reliable, suggesting the durometer might also perform well. ^{1 2 3 4 6}

Who Is on the Research Team?

Naida Cole, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center

Exclusion Criteria

Patients undergoing unscheduled (intrapartum) cesarean delivery

Non-English speaking patients

I cannot give consent on my own due to a mental or intellectual condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Use of a Shore durometer to measure uterine tone after placental delivery during cesarean section

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedural outcomes

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shore durometer

Trial Overview 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.

How Is the Trial Designed?

Group I: Durometer Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06284421

NCT06284421 | Durometer for Measuring Uterine Tone 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.

2. trial.medpath.com trial.medpath.com/clinical-trial/93a61f3007252c71/nct06284421-use-durometer-measure-uterine-tone-cesarean-delivery

Durometer for Measuring Uterine Tone | MedPath The primary outcome will be the ability to obtain reliable readings of the 'hardness' of the uterus during a cesarean delivery. Secondary Outcome Measures ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40214225/

Uterine Tone Numeric Rating Score as an Early Indicator of ... Uterine tone NRS was documented at 0 min after placental delivery in 91.6%, 5 min in 97.4%, and 10 min in 97.0% of cesarean deliveries. The 10- ...

4. withpower.com withpower.com/trial/phase-uterine-tone-disorders-1-2024-16940

Durometer for Uterine Tone During Cesarean Section 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.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33652161/

The interrater reliability and agreement of a 0 to 10 uterine ... Conclusion: The 0 to 10 numeric rating scale for uterine tone demonstrated good to excellent interrater reliability with 1 and 2 raters, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147752/

Uterine Tone Numeric Rating Score as an Early Indicator of ... Uterine tone NRS was documented at 0 min after placental delivery in 91.6%, 5 min in 97.4%, and 10 min in 97.0% of cesarean deliveries. The 10-min NRS was a ...