Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transperineal ultrasound cervical exam Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. |
Device: Butterfly iQ transperineal ultrasound exam
Transperineal ultrasound
|
| Active Comparator: Digital (manual) cervical exam Patients will undergo traditional digital cervical exam via examiner's fingers. |
Device: Butterfly iQ transperineal ultrasound exam
Transperineal ultrasound
|
Outcome Measures
Primary Outcome Measures
- Correlation of cervical dilation and length via Butterfly iQ pocket ultrasound in centimeters [9 months]
Compared to digital cervical exam
Secondary Outcome Measures
- Discomfort scale [9 months]
5-point Likert scale (0 = no discomfort, 4 = maximum) discomfort on questionnaire
- Preference for 1 exam over the other [9 months]
Circle yes or no on questionnaire
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Children's Hospital Pavilion for Women | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Baylor College of Medicine
Investigators
- Principal Investigator: Leah W Antoniewicz, MD, Baylor College of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. Review.
- 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.
- H-50937