DilaCheck Cervical Dilation Measurement Trial

NCT03440723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-06-22

Study results available
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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

Interventions

DEVICE

DilaCheck

Measuring device for the measurement of cervical dilation

DIAGNOSTIC_TEST

Cervical dilation examination

Sterile vaginal examination using subjective methods for measurement of cervical dilation

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER
  • Elm Tree Medical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440723 on ClinicalTrials.gov