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

NCT ID: NCT05260333

Last Updated: 2023-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-07-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervix; Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Patients will have a transperineal ultrasound followed by a traditional digital cervical exam.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

The investigator will not know the digital cervical exam value.

Study Groups

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

Patients will undergo transperineal cervical exam via Butterfly iQ ultrasound. Patients will then undergo traditional digital cervical exam via examiner's fingers.

Group Type EXPERIMENTAL

Butterfly iQ transperineal ultrasound exam

Intervention Type DEVICE

Transperineal ultrasound

Interventions

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Butterfly iQ transperineal ultrasound exam

Transperineal ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Leah Antoniewicz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leah W Antoniewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Texas Children's Hospital Pavilion for Women

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7724106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2277401 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8293582 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H-50937

Identifier Type: -

Identifier Source: org_study_id