Cervical Dilation, Labor Fast, Labor; Irregular, Labor Pain
Conditions
Keywords
Cervical Dilation, Dilation, Sterile vaginal examination
Brief summary
Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.
Detailed description
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.
Interventions
DEVICEDilaCheck
Measuring device for the measurement of cervical dilation
DIAGNOSTIC_TESTCervical dilation examination
Sterile vaginal examination using subjective methods for measurement of cervical dilation
Sponsors
Thomas Jefferson University
Elm Tree Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Masking description
Masking is not possible since physicians and participants will know whether they are using the device or not.
Intervention model description
Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The research population is pregnant women in the first stage of labor. Subjects eligible for inclusion in the study must be: pregnant women who are admitted to a Labor and Delivery unit for management or induction of labor in the first stage of labor, are able to give informed consent, are 18 years of age or greater, speak English, and have a gestational age greater than or equal to 37 weeks (i.e. term pregnancy). Patients are only consented if they have adequate pain control, either because they are not yet in labor (i.e. are admitted for an induction of labor) or have a functioning epidural.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interexaminer Agreement | Immediate upon examination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Examination | Immediate within 5 minutes of examinations | 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. |
| Ease of Use | Upon conclusion of the trial, <3 months from time of last examination with device | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment finalized at 42 due to COVID
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Standard Dilation Exam | Total | Dilation Exam With DilaCheck |
|---|---|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 5 | 28 years STANDARD_DEVIATION 5.3 | 29.1 years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 37 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Female | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
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
Population: All enrollees
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Dilation Exam | Interexaminer Agreement | 9 Participants |
| Dilation Exam With DilaCheck | Interexaminer Agreement | 4 Participants |
Secondary
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
Population: All providers who participated in the trial completed the survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Dilation Exam | Ease of Use | 7 Participants |
Secondary
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
Population: all enrollees
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Dilation Exam | Pain With Examination | 2.8 score on pain scale | Standard Deviation 2.8 |
| Dilation Exam With DilaCheck | Pain With Examination | 3.1 score on pain scale | Standard Deviation 2.9 |