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

Cervical Dilation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038891
• Other study ID #: 21-004735
• Status: Completed
• Start date: September 13, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dilation

Intervention

Diagnostic Test:
• Digital Cervical Exam
Standard Digital Cervical Exam by an experienced OB provider
• Transperineal Ultrasound
Self-administered transperineal ultrasound after instruction by a health care professional
• Transvaginal Ultrasound
Self-administered transvaginal ultrasound after instruction by a health care professional

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic Methodist Hospital	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)	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
Secondary	Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)	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