Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy

Study Overview
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Brief Summary
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The primary purpose of this study is to compare the accuracy of the Butterfly iQ pocket ultrasound with the digital cervical examination in the third trimester cervix. The secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.

Detailed Description
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Patients in the 3rd trimester that require a digital cervical exam (DCE) for assessment of labor will be approached. After informed consent is obtained, one of two study investigators will perform a transperineal ultrasound (TPUS) using the glove-covered Butterfly iQ+ probe. The Butterfly iQ+ does not have a transperineal probe or setting, therefore, the bladder preset setting will be used. The bladder setting has been predetermined to provide the best cervical images. This pocket ultrasound is FDA-approved and is the standard of care for point of care ultrasounds in many institutions and is already used in our department. The TPUS will be performed by 1 of the 2 investigators with digital calipers. There will be 3 measurements: dilation, effacement, and station. The dilation measurements with be made from the inside margins of the cervix . Effacement will be measured by marking the thinnest and most easily imaged lip of the cervix. Zero station will be assumed to be 5 cm above the perineum, with distances from 6-10 cm corresponding to -1 to -5 station clinically. An independent, blinded examiner will then perform a traditional digital cervical exam, which will be recorded in EPIC. The study investigators will be blinded to the DCE measurement until the end of the study. The patient will act as their own control. Additionally, the investigators will collect EGA, race, ethnicity, age, BMI, and indication for assessment of the cervix.

Official Title
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Use of a Pocket-device Point-of-care Ultrasound to Assess Cervical Dilation in Labor: Correlation and Patient Experience

Conditions
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Cervix; Pregnancy

Intervention / Treatment
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* Device: Butterfly iQ transperineal ultrasound exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery. Exclusion Criteria: Second trimester (less than 28 weeks) BMI>50 Does not wish to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional Model Description: Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transperineal ultrasound cervical exam followed by Digital (manual) cervical exam<br>Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Patients will then undergo traditional digital cervical exam via examiner's fingers. | Device: Butterfly iQ transperineal ultrasound exam<br>* Transperineal ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters | Dilation was measured on the day of the exam in centimeters. A correlation coefficient was then calculated to determine the relationship between the two exams. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort Scale | 3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire. | 1 day | 
| Preference for 1 Exam Over the Other | Patients were asked if they had a preference and circled yes or no on questionnaire | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transperineal, ultrasound, cervix, labor