DilaCheck Cervical Dilation Measurement Trial

NCT03440723 | Completed Results DMC FDA Device

• 1 other identifier: 16F.270
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dilation; Labor Pain; Labor Fast; Labor; Irregular

Keywords

Cervical Dilation; Dilation; Sterile vaginal examination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain With Examination

  Immediate within 5 minutes of examinations

• Ease of Use

  Upon conclusion of the trial, <3 months from time of last examination with device

Study Arms (2)

Standard Dilation Exam

ACTIVE COMPARATOR

Participants receive two standard digital cervical dilation examinations conducted by two different physicians.

Diagnostic Test: Cervical dilation examination

Dilation Exam with DilaCheck

EXPERIMENTAL

Participants receive two cervical dilation examinations using DilaCheck devices conducted by two different physicians.

Device: DilaCheck

Interventions

DilaCheck DEVICE

Measuring device for the measurement of cervical dilation

Dilation Exam with DilaCheck

Cervical dilation examination DIAGNOSTIC_TEST

Sterile vaginal examination using subjective methods for measurement of cervical dilation

Standard Dilation Exam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Elm Tree Medical Inc.: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 33582306 DERIVED

MeSH Terms

Conditions

Labor Pain; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Results Point of Contact

• Title: CEO
• Organization: Elm Tree Medical Inc.

evamartin@elmtreemedical.com

2158050862

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible since physicians and participants will know whether they are using the device or not.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 22, 2018
• Study Start: January 6, 2020
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: June 22, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)