Skip to main content
OpenTrials
Completed

NCT Number: NCT05038891

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Dilation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Cervical Exam

Diagnostic Test

Standard Digital Cervical Exam by an experienced OB provider

Transperineal ultrasound

Diagnostic Test

Self-administered transperineal ultrasound after instruction by a health care professional

Transvaginal ultrasound

Diagnostic Test

Self-administered transvaginal ultrasound after instruction by a health care professional

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2021
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.