Trial Outcomes & Findings for DilaCheck Cervical Dilation Measurement Trial (NCT NCT03440723)
NCT ID: NCT03440723
Last Updated: 2021-06-22
Results Overview
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."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Immediate upon examination
Results posted on
2021-06-22
Participant Flow
Recruitment finalized at 42 due to COVID
Participant milestones
| Measure |
Standard Dilation Exam
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation
|
Dilation Exam With DilaCheck
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
DilaCheck: Measuring device for the measurement of cervical dilation
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DilaCheck Cervical Dilation Measurement Trial
Baseline characteristics by cohort
| Measure |
Standard Dilation Exam
n=21 Participants
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation
|
Dilation Exam With DilaCheck
n=21 Participants
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
DilaCheck: Measuring device for the measurement of cervical dilation
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
29.1 years
STANDARD_DEVIATION 5.6 • n=107 Participants
|
28 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediate upon examinationPopulation: All enrollees
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."
Outcome measures
| Measure |
Standard Dilation Exam
n=21 Participants
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation
|
Dilation Exam With DilaCheck
n=21 Participants
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
DilaCheck: Measuring device for the measurement of cervical dilation
|
|---|---|---|
|
Interexaminer Agreement
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Immediate within 5 minutes of examinationsPopulation: all enrollees
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.
Outcome measures
| Measure |
Standard Dilation Exam
n=21 Participants
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation
|
Dilation Exam With DilaCheck
n=21 Participants
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
DilaCheck: Measuring device for the measurement of cervical dilation
|
|---|---|---|
|
Pain With Examination
|
2.8 score on pain scale
Standard Deviation 2.8
|
3.1 score on pain scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Upon conclusion of the trial, <3 months from time of last examination with devicePopulation: All providers who participated in the trial completed the survey
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.
Outcome measures
| Measure |
Standard Dilation Exam
n=10 Participants
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Cervical dilation examination: Sterile vaginal examination using subjective methods for measurement of cervical dilation
|
Dilation Exam With DilaCheck
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
DilaCheck: Measuring device for the measurement of cervical dilation
|
|---|---|---|
|
Ease of Use
|
7 Participants
|
—
|
Adverse Events
Standard Dilation Exam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dilation Exam With DilaCheck
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place