Back to resultsDilaCheck Cervical Dilation Measurement Trial
Primary Purpose
Cervical Dilation, Labor Pain, Labor Fast
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DilaCheck
Cervical dilation examination
Sponsored by
About this trial
This is an interventional device feasibility trial for Cervical Dilation focused on measuring Cervical Dilation, Dilation, Sterile vaginal examination
Eligibility Criteria
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.
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Dilation Exam
Dilation Exam with DilaCheck
Arm Description
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03440723
First Posted
February 7, 2018
Last Updated
May 29, 2021
Sponsor
Elm Tree Medical Inc.
Collaborators
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT03440723
Brief Title
DilaCheck Cervical Dilation Measurement Trial
Official Title
Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elm Tree Medical Inc.
Collaborators
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dilation, Labor Pain, Labor Fast, Labor; Irregular
Keywords
Cervical Dilation, Dilation, Sterile vaginal examination
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
Masking
None (Open Label)
Masking Description
Masking is not possible since physicians and participants will know whether they are using the device or not.
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Dilation Exam
Arm Type
Active Comparator
Arm Description
Participants receive two standard digital cervical dilation examinations conducted by two different physicians.
Arm Title
Dilation Exam with DilaCheck
Arm Type
Experimental
Arm Description
Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.
Intervention Type
Device
Intervention Name(s)
DilaCheck
Intervention Description
Measuring device for the measurement of cervical dilation
Intervention Type
Diagnostic Test
Intervention Name(s)
Cervical dilation examination
Intervention Description
Sterile vaginal examination using subjective methods for measurement of cervical dilation
Primary Outcome Measure Information:
Title
Interexaminer Agreement
Description
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
Secondary Outcome Measure Information:
Title
Pain With Examination
Description
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
Title
Ease of Use
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33582306
Citation
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.
Results Reference
derived
Learn more about this trial
DilaCheck Cervical Dilation Measurement Trial
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