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

NCT05038891 | Completed

• 1 other identifier: 21-004735
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cervical Dilation

Keywords

Cervical Effacement; Cervical Dilation; Labor; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.

  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 Outcomes (2)

• Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)

  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)

  On day of induction after first cervical examination during first assessment, through study completion up to 6 months

Study Arms (2)

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; Diagnostic Test: Transperineal Ultrasound; Diagnostic Test: Transvaginal Ultrasound

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; Diagnostic Test: Transperineal Ultrasound; Diagnostic Test: Transvaginal Ultrasound

Interventions

Digital Cervical Exam DIAGNOSTIC_TEST

Standard Digital Cervical Exam by an experienced OB provider

Digital Cervical Assessment performed first; Ultrasound Assessment performed first

Transperineal Ultrasound DIAGNOSTIC_TEST

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

Digital Cervical Assessment performed first; Ultrasound Assessment performed first

Transvaginal Ultrasound DIAGNOSTIC_TEST

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

Digital Cervical Assessment performed first; Ultrasound Assessment performed first

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Methodist Hospital

Rochester, Minnesota, 55929, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Regan N Theiler, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Megan Miller, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 9, 2021
• Study Start: September 13, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)