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

Baylor College of Medicine

Status: Completed

Conditions: Cervix; Pregnancy

Treatments: Device: Butterfly iQ transperineal ultrasound exam

Study type: Interventional

Funder types: Other

Identifiers

NCT05260333

H-50937

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Transperineal ultrasound cervical exam followed by Digital (manual) cervical exam

Experimental group

Description:

Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Patients will then undergo traditional digital cervical exam via examiner's fingers.

Treatment:

Device: Butterfly iQ transperineal ultrasound exam