DilaCheck Cervical Dilation Measurement Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial

Conditions
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Cervical Dilation, Labor Pain, Labor Fast, Labor; Irregular

Intervention / Treatment
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* Device: DilaCheck
* Diagnostic Test: Cervical dilation examination


Participation Criteria
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Eligibility Criteria
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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: Exclusion criteria include progression to the second stage of labor (i.e. known dilation of ten centimeters), known rupture of membranes, any condition that renders labor unsafe for the patient (e.g. cardiac conditions, pulmonary hypertension) and any other condition that necessitates an emergent or urgent cesarean section (e.g. non-reassuring fetal status, placental abruption, hemorrhage, cord prolapse). All participants are necessarily female due to the subject matter. Given the vulnerability of pregnant patients under the age of 18, this study will exclude children. There are no restrictions on eligibility based on race or ethnicity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Dilation Exam<br>Participants receive two standard digital cervical dilation examinations conducted by two different physicians. | Diagnostic Test: Cervical dilation examination<br>* Sterile vaginal examination using subjective methods for measurement of cervical dilation<br>|
| Experimental: Dilation Exam with DilaCheck<br>Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians. | Device: DilaCheck<br>* Measuring device for the measurement of cervical dilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Dilation, Dilation, Sterile vaginal examination