Self-Obtained Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor

April 9, 2024 updated by: Regan N. Theiler, Mayo Clinic

Self-Obtained Transperineal and Transvaginal Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor: Implications for Telemedicine and Home Hospital in Obstetrics

This is a pilot study to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and effacement in pregnant women undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective will assess correlation of cervical measurements with gold standard of provider digital cervical examinations and self-obtained transperineal and transvaginal images. Experienced providers performing digital cervical examinations will be blinded to ultrasound images and measurements. The maternal-fetal medicine subspecialist interpreting the ultrasound images will be blinded to patient details and will document ultrasound measurement of cervical dilation of the internal cervical os as the mean of anterior-posterior and transverse measurements and cervical length. 2-D ultrasound images and cine clips will be obtained at up to five different time points during the induction of labor.

As as secondary objective, participant discomfort and anxiety will be measured following the initial set of cervical measurements using the Visual Analog Scale and Six-Item State-Trait Anxiety Inventory.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55929
        • Mayo Clinic Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This pilot study will enroll pregnant women undergoing induction of labor at the Family Birth Center at Mayo Clinic Hospital in Rochester, MN. The target population will include women with a singleton fetus at gestational age greater than 28 weeks 0 days gestation who have intact membrane status at time of induction of labor.

Description

Inclusion Criteria:

  • Pregnant females age 18 years or older
  • Third trimester of pregnancy with a singleton fetus (gestational age >28 weeks)
  • Pre-gestational body mass index <40
  • Scheduled for induction of labor
  • Eligible for induction of labor based on current birth center guidelines
  • Intact membranes when presenting for induction of labor

Exclusion Criteria:

  • History of prior cervical loop electrosurgical excisional procedure or cold knife conization
  • Cerclage placement during current pregnancy
  • Positive COVID-19 test within 7 days of admission for induction of labor
  • Fever > 38.0 C at time of admission for induction of labor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Digital Cervical Assessment performed first
A digital cervical exam will be performed by an experienced senior obstetrics and gynecology resident, using index finger and middle finger to measure the dilation and thickness of the cervix. This is the gold standard measurement utilized to assess the labor course. In this group, the digital cervical exam is done first, followed by a participant-performed ultrasound imaging assessment of the cervix.
Diagnostic test: Digital Cervical Exam
Standard Digital Cervical Exam by an experienced OB provider
Diagnostic test: Transperineal Ultrasound
Self-administered transperineal ultrasound after instruction by a health care professional
Diagnostic test: Transvaginal Ultrasound
Self-administered transvaginal ultrasound after instruction by a health care professional
Ultrasound Assessment performed first
Ultrasound imaging will be first taught by an experienced RN, then self-performed by the participant in the presence of junior obstetrics and gynecology resident and the RN. The junior resident will ensure the ultrasound device is functioning properly and the images are saved. In this group, the participant-performed imaging assessment is done first, followed by a digital cervical exam performed by an experienced senior obstetrics and gynecology resident.
Diagnostic test: Digital Cervical Exam
Standard Digital Cervical Exam by an experienced OB provider
Diagnostic test: Transperineal Ultrasound
Self-administered transperineal ultrasound after instruction by a health care professional
Diagnostic test: Transvaginal Ultrasound
Self-administered transvaginal ultrasound after instruction by a health care professional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
Time Frame: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
Data collection will occur at up to five time points along a participant's labor course. Providers will be blinded to ultrasound images. Data includes provider digital exam, transperineal ultrasound cine clip with mean (anterior-posterior and transverse) measurement of internal os and total cervical length and transvaginal ultrasound cine clips with mean (anterior-posterior and transverse) measurement of internal os and total cervical length. Ultrasound images will be read by maternal-fetal medicine subspecialist blinded to patient information, labor stage and provider cervical examination.
Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)
Time Frame: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
The Visual Analog Scale values range from 0 to 10 where higher values indicate more pain and will be assessed once after the first cervical examination.
On day of induction after first cervical examination during first assessment, through study completion up to 6 months
Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)
Time Frame: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
The 6 items which are on a 4 point likert scale will be administered to participants post first cervical exam. The 6 items are summed, divided by 6 and hen multiplied by 20 to give a range of 20 to 80. Higher scores indicate more anxiety.
On day of induction after first cervical examination during first assessment, through study completion up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Regan N Theiler, M.D., Mayo Clinic
  • Study Chair: Megan Miller, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-004735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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