NCT03440723

DilaCheck Cervical Dilation Measurement Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Elm Tree Medical Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2018-02-22
• Last updated: 2021-06-22
• Results posted: 2021-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study