Durometer for Measuring Uterine Tone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Chicago
About this trial
This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center
Patients ages 18-50
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Shore durometer
DeviceThe durometer will be held on the exterior of the lower uterine segment and fundus to measure the hardness reading at each location.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: DurometerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within 10 minutes after placental deliverySecondary outcomes
1
durometer reading
average durometer reading at lower uterine segment and fundus
Time frame
0 minutes after placental delivery2
durometer reading
average durometer reading at lower uterine segment and fundus
Time frame
3 minutes after placental delivery3
durometer reading
average durometer reading at lower uterine segment and fundus
Time frame
10 minutes after placental delivery4
correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")
correlation of 2 measures
Time frame
0 minutes after placental deliverySponsors and contacts
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Source ClinicalTrials.gov