DilaCheck Cervical Dilation Measurement Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-03-30

Brief Summary

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Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.

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Detailed Description

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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

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Cervical Dilation Labor Pain Labor Fast Labor; Irregular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Masking is not possible since physicians and participants will know whether they are using the device or not.

Study Groups

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Standard Dilation Exam

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

Group Type ACTIVE_COMPARATOR

Cervical dilation examination

Intervention Type DIAGNOSTIC_TEST

Sterile vaginal examination using subjective methods for measurement of cervical dilation

Dilation Exam with DilaCheck

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

Group Type EXPERIMENTAL

DilaCheck

Intervention Type DEVICE

Measuring device for the measurement of cervical dilation

Interventions

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DilaCheck

Measuring device for the measurement of cervical dilation

Intervention Type DEVICE

Cervical dilation examination

Sterile vaginal examination using subjective methods for measurement of cervical dilation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No