A Study to Evaluate Ultrasound Scans to Measure Cervical Dilation and Effacement in Labor
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-004735
NCT ID: NCT05038891
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.
More information
Publications
Publications are currently not available