Clinical trial NCT05260333: Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy
Official title: Use of a Pocket-device Point-of-care Ultrasound to Assess Cervical Dilation in Labor: Correlation and Patient Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervix; Pregnancy
Keywords: transperineal
ultrasound
cervix
labor
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters
timeFrame: 1 day
Secondary outcomes:
measure: Discomfort Scale
timeFrame: 1 day
measure: Preference for 1 Exam Over the Other
timeFrame: 1 day
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital Pavilion for Women
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Leah W Antoniewicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richey SD, Ramin KD, Roberts SW, Ramin SM, Cox SM, Twickler DM. The correlation between transperineal sonography and digital examination in the evaluation of the third-trimester cervix. Obstet Gynecol. 1995 May;85(5 Pt 1):745-8. doi: 10.1016/0029-7844(95)00027-o.
citation: Mahony BS, Nyberg DA, Luthy DA, Hirsch JH, Hickok DE, Petty CN. Translabial ultrasound of the third-trimester uterine cervix. Correlation with digital examination. J Ultrasound Med. 1990 Dec;9(12):717-23. doi: 10.7863/jum.1990.9.12.717.
citation: Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004.