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Completed

NCT Number: NCT05260333

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Children's Hospital Pavilion for Women

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butterfly iQ transperineal ultrasound exam

Device

Transperineal ultrasound

Primary outcomes

  1. Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters

    Time frame: 1 day

    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.

Secondary outcomes

  1. Discomfort Scale

    Time frame: 1 day

    3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire.

  2. Preference for 1 Exam Over the Other

    Time frame: 1 day

    Patients were asked if they had a preference and circled yes or no on questionnaire

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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