Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.
The trial seeks to compare the DilaCheck device with standard digital cervical dilation examinations. 50 laboring female participants will be enrolled with 25 randomly assigned to the control arm and 25 to the treatment (DilaCheck) arm. Each participant will receive two cervical dilation examinations from two separate physicians. The main outcome measure is agreement between the two cervical dilation measurements. Secondary outcomes include ease of use of the device and pain levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
42
Measuring device for the measurement of cervical dilation
Sterile vaginal examination using subjective methods for measurement of cervical dilation
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Interexaminer Agreement
Agreement between 2 cervical dilation measurements taken by 2 different physicians. If the measurements are the same, the outcome is "agree." If the measurements are different, the outcome is "disagree."
Time frame: Immediate upon examination
Pain With Examination
Scores on a Scale. Subjective experience of pain during dilation examinations as measured by scores on a scale given to patient participants following the cervical dilation examinations. The pain measurement is a scale of 1 to 10 with 1 being no pain and 10 being extreme pain. The participant enters a number from 1 to 10 on the survey.
Time frame: Immediate within 5 minutes of examinations
Ease of Use
Ease of Use of the device as reported by physician users on a paper survey administered to them. Reported is number of physicians who reported device is easy to use.
Time frame: Upon conclusion of the trial, <3 months from time of last examination with device
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.