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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05038891
Study type Observational
Source Mayo Clinic
Contact Jane R Gillespie, BSN
Phone 507-266-3382
Email [email protected]
Status Recruiting
Phase
Start date September 13, 2021
Completion date May 30, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04437576 - Pregnancy and Latent Labor Biomarkers and Symptoms to Predict Cervical Dilation at Hospital Admission.
Completed NCT02606643 - Balloon Catheter for Cervical Ripening N/A
Completed NCT03440723 - DilaCheck Cervical Dilation Measurement Trial N/A
Not yet recruiting NCT04529837 - Ultrasound Evaluation of Cervical Dilation Using DILAPAN-S (USE-Dilapan)