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

NCT05260333 | Completed Results FDA Device

• 1 other identifier: H-50937
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix; Pregnancy

Keywords

transperineal; ultrasound; cervix; labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Discomfort Scale

  1 day

• Preference for 1 Exam Over the Other

  1 day

Study Arms (1)

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.

Device: Butterfly iQ transperineal ultrasound exam

Interventions

Butterfly iQ transperineal ultrasound exam DEVICE

Transperineal ultrasound

Transperineal ultrasound cervical exam followed by Digital (manual) cervical exam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery.

You may not qualify if:

• Second trimester (less than 28 weeks)
• BMI\>50
• Does not wish to participate

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital Pavilion for Women

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 7724106 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.

  PMID: 2277401 BACKGROUND

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

  PMID: 8293582 BACKGROUND

Results Point of Contact

• Title: Dr. Leah Antoniewicz, MD-PI
• Organization: Baylor College of Medicine

leah.antoniewicz@bcm.edu

832-8267458

Study Officials

• Leah W Antoniewicz, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigator will not know the digital cervical exam value.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: November 27, 2023
• Results First Posted: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)