Self-Obtained Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor
Recruiting at1 trial location
RN
Overseen byRegan N Theiler, M.D.
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
RN
Regan N Theiler, M.D.
Principal Investigator
Mayo Clinic
MM
Megan Miller, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
See 1 more
Treatment Details
Interventions
- Digital Cervical Exam (Diagnostic Test)
- Self-Directed Ultrasound Imaging (Ultrasound)
- Transperineal Ultrasound (Diagnostic Test)
- Transvaginal Ultrasound (Diagnostic Test)
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
Dr. Gianrico Farrugia
Mayo Clinic
Chief Executive Officer since 2019
MD from University of Malta Medical School
Dr. Richard Afable
Mayo Clinic
Chief Medical Officer
MD from Loyola Stritch School of Medicine