A Study to Evaluate Ultrasound Scans to Measure Cervical Dilation and Effacement in Labor

Overview

About this study

The purpose of this study is to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and length in participants undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations. Experienced providers performing digital cervical examinations will be blinded to ultrasound images and measurements.  Participants will be randomized to undergoing digital cervical examination or ultrasound imaging as initial modality to assess cervical measurements.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Females, 18 years of age or older.
  • Carrying singleton pregnancies in the third trimester.
  • Have a pregestational BMI < 40 and present for scheduled induction.
  • Patients must be medically eligible for induction of labor per routine obstetric practice guidelines. 
  • The decision to induce labor will be made by the patient and provider in advance and independent of the current study enrollment.

Exclusion Criteria:

  • Participants that have a history of prior cervical LEEP or cold knife conization.
  • Cerclage during current pregnancy.
  • Prelabor rupture of membranes as defined as rupture for 5 greater than six hours prior to induction of labor.
  • Positive COVID-19 test within 7 days of admission.
  • Fever at the time of admission.

Eligibility last updated 11/22/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Regan Theiler, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20520845

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