CompletedNot Applicable

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

United States40 participantsStarted 2021-09-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.

Timeframe: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months

Trial details

NCT IDNCT05038891

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Cervical Dilation trials