Cervical DilationNCT03440723
DilaCheck Cervical Dilation Measurement Trial
A study testing DilaCheck and Cervical dilation examination in people with Cervical Dilation and Labor Pain, run by Elm Tree Medical Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dilation, Labor Pain, Labor Fast
- What is being tested?
- DilaCheck and Cervical dilation examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial
Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.
Read the 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.
- Conditions
- Cervical Dilation, Labor Pain, Labor Fast, Labor; Irregular
- Being tested
- DilaCheck, Cervical dilation examination
- Keywords
- Cervical Dilation, Dilation, Sterile vaginal examination
- Medical subject headings
- Labor Pain, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DilaCheckDevice
Measuring device for the measurement of cervical dilation
Cervical dilation examinationDiagnostic test
Sterile vaginal examination using subjective methods for measurement of cervical dilation
| Study group | Role | What they receive |
|---|---|---|
| Standard Dilation Exam | Active comparator | Participants receive two standard digital cervical dilation examinations conducted by two different physicians. Receives: Diagnostic Test: Cervical dilation examination |
| Dilation Exam with DilaCheck | Experimental | Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians. Receives: Device: DilaCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Immediate upon examination
Secondary outcomes (2)
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.
Measured: 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.
Measured: Upon conclusion of the trial, <3 months from time of last examination with device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start6 Jan 2020
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elm Tree Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440723
- Sponsor's protocol ID
- 16F.270
- Status last verified
- May 2021
- First submitted
- 7 Feb 2018
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33582306
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03440723
- Acronym / sponsor ID
- 16F.270
- Conditions
- Cervical Dilation, Labor Pain, Labor Fast, Labor; Irregular
- Keywords
- Cervical Dilation, Dilation, Sterile vaginal examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Elm Tree Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
| Arm | Type | Receives |
|---|---|---|
| Standard Dilation Exam | Active comparator | Diagnostic Test: Cervical dilation examinationParticipants receive two standard digital cervical dilation examinations conducted by two different physicians. |
| Dilation Exam with DilaCheck | Experimental | Device: DilaCheckParticipants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DilaCheckMeasuring device for the measurement of cervical dilation | Device | Dilation Exam with DilaCheck |
| Cervical dilation examinationSterile vaginal examination using subjective methods for measurement of cervical dilation | Diagnostic test | Standard Dilation Exam |
Primary outcome
Interexaminer Agreement
Time frame: 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."
2 secondary outcomes
Pain With Examination
Time frame: Immediate within 5 minutes of examinations
Ease of Use
Time frame: Upon conclusion of the trial, <3 months from time of last examination with device
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33582306Martin 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.
- Individual participant dataSharing planned: No
Related trials for Cervical Dilation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DilaCheck and Cervical dilation examination in people with Cervical Dilation and Labor Pain, run by Elm Tree Medical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interexaminer Agreement (time frame: Immediate upon examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.