Trial Outcomes & Findings for Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy (NCT NCT05260333)

NCT ID: NCT05260333

Last Updated: 2023-11-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2023-11-27

Participant Flow

The first patient was enrolled in April of 2022, and last patient was seen in July of 2022.

Participant milestones

Measure	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
Overall Study STARTED	30
Overall Study Transperineal Ultrasound	30
Overall Study Digital Cervical Exam	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy

Baseline characteristics by cohort

Measure	Transperineal Ultrasound Cervical Exam and Digital (Manual) Cervical Exam n=30 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Cervical Dilation	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: The patients served as their own control.

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.

Outcome measures

Measure	Transperineal Ultrasound Cervical Exam Dilation n=30 Participants Diameter of cervix in centimeters	Digital (Manual) Cervical Exam Dilation n=30 Participants Diameter of cervix in centimeters
Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters	5.1 centimeters Interval 0.0 to 10.0	5 centimeters Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 1 day

3-point Likert scale (0 = no discomfort, 3 = maximum) discomfort on questionnaire.

Outcome measures

Measure	Transperineal Ultrasound Cervical Exam Dilation n=30 Participants Diameter of cervix in centimeters	Digital (Manual) Cervical Exam Dilation Diameter of cervix in centimeters
Discomfort Scale Transperineal	0 score on a scale Interval 0.0 to 2.0	—
Discomfort Scale Digital	2 score on a scale Interval 0.0 to 2.0	—

SECONDARY outcome

Timeframe: 1 day

Patients were asked if they had a preference and circled yes or no on questionnaire

Outcome measures

Measure	Transperineal Ultrasound Cervical Exam Dilation n=30 Participants Diameter of cervix in centimeters	Digital (Manual) Cervical Exam Dilation Diameter of cervix in centimeters
Preference for 1 Exam Over the Other Preferred TPUS	30 Participants	—
Preference for 1 Exam Over the Other Preferred Digital	0 Participants	—

Adverse Events

Transperineal Ultrasound Cervical Exam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Digital (Manual) Cervical Exam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Leah Antoniewicz, MD-PI

Baylor College of Medicine

Phone: 832-8267458

Email: leah.antoniewicz@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place