Uterine Tone DisordersNCT06284421
Durometer for Measuring Uterine Tone
A study testing Shore durometer in people with Uterine Tone Disorders and Cesarean Section Complications, run by University of Chicago at 1 site in United States.
Trial summary
This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Tone Disorders, Cesarean Section Complications
- What is being tested?
- Shore durometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center
- Patients ages 18-50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Naida M Cole, MD, 773-702-6700, nmcole@bsd.uchicago.edu
Somayeh Mohammadi, 17738343274, mohammadis@bsd.uchicago.edu
About this study
Official title: Use of a Durometer to Measure Uterine Tone in Cesarean Delivery
This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.
Read the 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.
- Being tested
- Shore durometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shore durometerDevice
The durometer will be held on the exterior of the lower uterine segment and fundus to measure the hardness reading at each location.
| Study group | Role | What they receive |
|---|---|---|
| Durometer | Experimental | 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. Receives: Device: Shore durometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of a durometer
The primary outcome will be the ability to obtain reliable readings of the 'hardness' of the uterus during a cesarean delivery.
Measured: within 10 minutes after placental delivery
Secondary outcomes (6)
durometer reading
average durometer reading at lower uterine segment and fundus
Measured: 0 minutes after placental delivery
durometer reading
average durometer reading at lower uterine segment and fundus
Measured: 3 minutes after placental delivery
durometer reading
average durometer reading at lower uterine segment and fundus
Measured: 10 minutes after placental delivery
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
correlation of 2 measures
Measured: 0 minutes after placental delivery
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
correlation of 2 measures
Measured: 3 minutes after placental delivery
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
correlation of 2 measures
Measured: 10 minutes after placental delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start8 Feb 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Tone DisordersStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naida Cole, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284421
- Sponsor's protocol ID
- IRB23-1068
- Status last verified
- May 2025
- First submitted
- 13 Feb 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Durometer to Measure Uterine Tone in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06284421
- Acronym / sponsor ID
- IRB23-1068
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Durometer | Experimental | Device: Shore durometerThis 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 may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center
- Patients ages 18-50
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shore durometerThe durometer will be held on the exterior of the lower uterine segment and fundus to measure the hardness reading at each location. | Device | Durometer |
Primary outcome
feasibility of a durometer
Time frame: 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.
6 secondary outcomes
durometer reading
Time frame: 0 minutes after placental delivery
durometer reading
Time frame: 3 minutes after placental delivery
durometer reading
Time frame: 10 minutes after placental delivery
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
Time frame: 0 minutes after placental delivery
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
Time frame: 3 minutes after placental delivery
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
Time frame: 10 minutes after placental delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
Related trials for Uterine Tone Disorders
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Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
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Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia
Cesarean Section, Hypotension
RecruitingPhase 2
Oxytocin Pharmacokinetics and Pharmacodynamics
Post Partum Hemorrhage, Cesarean Section Complications
Not yet recruiting
Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone
Postpartum Hemorrhage, Uterine Atony
Recruiting
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Postpartum Hemorrhage (Primary)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naida Cole, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shore durometer in people with Uterine Tone Disorders and Cesarean Section Complications, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Al McAuley ((773) 834-3274, amcauley1@dacc.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of a durometer (time frame: within 10 minutes after placental delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.