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| Name | Class |
|---|---|
| Thomas Jefferson University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dilation Exam | Active Comparator | Participants receive two standard digital cervical dilation examinations conducted by two different physicians. |
|
| Dilation Exam with DilaCheck | Experimental | Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DilaCheck | Device | Measuring device for the measurement of cervical dilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Immediate upon examination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate within 5 minutes of examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33582306 | Derived | Martin EL, Firman B, Berghella V. Novel device vs manual examinations for the measurement of cervical dilation in labor: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 May;3(3):100328. doi: 10.1016/j.ajogmf.2021.100328. Epub 2021 Feb 11. |
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Recruitment finalized at 42 due to COVID
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Dilation Exam With DilaCheck |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | All enrollees | Posted | Count of Participants | Participants | Immediate upon examination |
|
30-90 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CEO | Elm Tree Medical Inc. | 2158050862 | evamartin@elmtreemedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2019 | May 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
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Masking is not possible since physicians and participants will know whether they are using the device or not.
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| Cervical dilation examination | Diagnostic Test | Sterile vaginal examination using subjective methods for measurement of cervical dilation |
|
| 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. | Upon conclusion of the trial, <3 months from time of last examination with device |
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians. DilaCheck: Measuring device for the measurement of cervical dilation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
DilaCheck: Measuring device for the measurement of cervical dilation
|
|
| 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. | all enrollees | Posted | Mean | Standard Deviation | score on pain scale | Immediate within 5 minutes of examinations |
|
|
|
| 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. | All providers who participated in the trial completed the survey | Posted | Count of Participants | Participants | Upon conclusion of the trial, <3 months from time of last examination with device |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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 | 0 | 21 | 0 | 21 | 0 | 21 |
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| D020763 | Pathological Conditions, Anatomical |