An interventional study of DilaCheck and Cervical dilation examination in Cervical Dilation, Labor Pain and Labor Fast, sponsored by Elm Tree Medical Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Elm Tree Medical Inc. · Not applicable, Interventional, and Device feasibility
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.
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's enrollment of 42 is below the median of 100 across 347 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →This is the only study on the registry with Elm Tree Medical Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Diagnostic Test: Cervical dilation examination
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
Device: DilaCheck
Measuring device for the measurement of cervical dilation
Sterile vaginal examination using subjective methods for measurement of cervical dilation
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
Recruitment finalized at 42 due to COVID
| Milestone | Standard Dilation Exam | Dilation Exam With DilaCheck |
|---|---|---|
| Started | 21 | 21 |
| Completed | 21 | 21 |
| Not completed | 0 | 0 |
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."
| Participants | Standard Dilation Exam | Dilation Exam With DilaCheck |
|---|---|---|
| Interexaminer Agreement | 9 | 4 |
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.
| score on pain scale | Standard Dilation Exam | Dilation Exam With DilaCheck |
|---|---|---|
| Pain With Examination | 2.8 ± 2.8 | 3.1 ± 2.9 |
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.
| Participants | Providers Participating in Trial |
|---|---|
| Ease of Use | 7 |
Collected over 30-90 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Dilation Exam | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Dilation Exam With DilaCheck | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Standard Dilation Exam | Dilation Exam With DilaCheck | Total |
|---|---|---|---|
| Mean | 26.8 ± 5.0 | 29.1 ± 5.6 | 28 ± 5.3 |
| Sex: Female, Male(Participants) | Standard Dilation Exam | Dilation Exam With DilaCheck | Total |
|---|---|---|---|
| Female | 21 | 21 | 42 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Standard Dilation Exam | Dilation Exam With DilaCheck | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 18 | 19 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard Dilation Exam | Dilation Exam With DilaCheck | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 9 | 24 |
| White | 6 | 7 | 13 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Standard Dilation Exam | Dilation Exam With DilaCheck | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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