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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05260333
Other study ID # H-50937
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date July 27, 2022

Study information

Verified date November 2023
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 27, 2022
Est. primary completion date July 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Butterfly iQ transperineal ultrasound exam
Transperineal ultrasound

Locations

Country Name City State
United States Texas Children's Hospital Pavilion for Women Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004. — View 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. — View Citation

Outcome

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