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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transperineal ultrasound cervical exam followed by Digital (manual) cervical exam | Experimental | Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Patients will then undergo traditional digital cervical exam via examiner's fingers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butterfly iQ transperineal ultrasound exam | Device | Transperineal ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort Scale | 3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire. | 1 day |
| Preference for 1 Exam Over the Other | Patients were asked if they had a preference and circled yes or no on questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leah W Antoniewicz, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital Pavilion for Women | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7724106 | Background | 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. | |
| 2277401 | Background | 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. |
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The first patient was enrolled in April of 2022, and last patient was seen in July of 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transperineal Ultrasound and Digital Cervical Exam | Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound followed by a traditional digital cervical exam. Butterfly iQ transperineal ultrasound exam: Transperineal ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transperineal Ultrasound Cervical Exam and Digital (Manual) Cervical Exam | Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound and then undergo traditional digital cervical exam via examiner's fingers.. Butterfly iQ transperineal ultrasound exam: Transperineal ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Collected from chart |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The patients served as their own control. | Posted | Median | Full Range | centimeters | 1 day |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transperineal Ultrasound Cervical Exam | Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Butterfly iQ transperineal ultrasound exam: Transperineal ultrasound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leah Antoniewicz, MD-PI | Baylor College of Medicine | 832-8267458 | leah.antoniewicz@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2021 | Jun 25, 2023 | Prot_SAP_001.pdf |
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Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.
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The investigator will not know the digital cervical exam value.
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| 1 day |
| 8293582 | Background | Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cervical Dilation | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Discomfort Scale | 3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire. | Posted | Median | Full Range | score on a scale | 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 | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Digital (Manual) Cervical Exam | Patients will undergo traditional digital cervical exam via examiner's fingers. Butterfly iQ transperineal ultrasound exam: Transperineal ultrasound | 0 | 30 | 0 | 30 | 0 | 30 |
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