Cervix; Pregnancy
Conditions
Keywords
transperineal, ultrasound, cervix, labor
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.
Interventions
DEVICEButterfly iQ transperineal ultrasound exam
Transperineal ultrasound
Sponsors
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The investigator will not know the digital cervical exam value.
Intervention model description
Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters | 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
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Scale | 1 day | 3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire. |
| Preference for 1 Exam Over the Other | 1 day | Patients were asked if they had a preference and circled yes or no on questionnaire |
Countries
United States
Participant flow
Recruitment details
The first patient was enrolled in April of 2022, and last patient was seen in July of 2022.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Transperineal Ultrasound Cervical Exam and Digital (Manual) Cervical Exam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Cervical Dilation | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 1 day
Population: The patients served as their own control.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transperineal Ultrasound Cervical Exam Dilation | Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters | 5.1 centimeters |
| Digital (Manual) Cervical Exam Dilation | Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters | 5 centimeters |
p-value: 0.0001Wilcoxon (Mann-Whitney)
Secondary
Discomfort Scale
3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire.
Time frame: 1 day
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transperineal Ultrasound Cervical Exam Dilation | Discomfort Scale | Transperineal | 0 score on a scale |
| Transperineal Ultrasound Cervical Exam Dilation | Discomfort Scale | Digital | 2 score on a scale |
Secondary
Preference for 1 Exam Over the Other
Patients were asked if they had a preference and circled yes or no on questionnaire
Time frame: 1 day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Transperineal Ultrasound Cervical Exam Dilation | Preference for 1 Exam Over the Other | Preferred TPUS | 30 Participants |
| Transperineal Ultrasound Cervical Exam Dilation | Preference for 1 Exam Over the Other | Preferred Digital | 0 Participants |