← Back to Search

Ultrasound

Digital Cervical Assessment performed first for Cervical Dilatation

N/A
Waitlist Available
Led By Regan N Theiler, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Cervical Dilatation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and data collection during induction of labor with image interpretation through end of study, assessed up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
Secondary outcome measures
Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)
Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ultrasound Assessment performed firstExperimental Treatment3 Interventions
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.
Group II: Digital Cervical Assessment performed firstExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Cervical Exam
2021
N/A
~40
Transperineal Ultrasound
2021
N/A
~260
Transvaginal Ultrasound
2021
Completed Phase 4
~1000

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,253 Previous Clinical Trials
3,835,190 Total Patients Enrolled
Regan N Theiler, M.D.Principal InvestigatorMayo Clinic
Megan Miller, M.D.Study ChairMayo Clinic
~11 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top