NCT06822647 Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey
| NCT ID | NCT06822647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry Ford Health System |
| Condition | Cervical Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-06-01 |
Trial Parameters
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Brief Summary
The goal of this clinical trial is to determine the optimal timing for measuring cervical length (CL) during fetal anatomy surveys in pregnant individuals. This study focuses on improving the accuracy of cervical length assessments, which are critical for identifying individuals at risk for preterm birth. The main questions it aims to answer are: * Does measuring cervical length at the beginning of the anatomy survey result in a higher proportion of scans meeting the nine CLEAR (Cervical Length Education and Review) criteria compared to measuring at the end of the survey? * Does the use of sepia-filtered ultrasound images improve the proportion of scans meeting the nine CLEAR criteria compared to conventional grayscale images? Researchers will compare two groups of participants randomized to have cervical length measured either at the beginning or at the end of the anatomy survey. Additionally, all participants will undergo cervical length measurements using both grayscale and sepia-filtered ultrasound imaging. Participants will: * Receive a patient information sheet through MyChart explaining the study and standard cervical length screening during anatomy surveys. * Provide verbal consent for a transvaginal ultrasound and study participation. * Be randomized to have their cervical length measured at either the start or end of the fetal survey. * Undergo cervical length measurement using both grayscale and sepia-filtered ultrasound imaging modalities. * This study involves no additional risks beyond those of routine clinical care and aims to enhance clinical practice by identifying optimal methods for cervical length assessment during pregnancy.
Eligibility Criteria
Inclusion Criteria: * Pregnant individuals between 16 weeks and 23 weeks + 6 days of gestation. * Presenting for a fetal anatomy survey at Henry Ford Health MFM ultrasound units. * Consent to a transvaginal cervical length measurement as part of routine care. * Agreement to participate in the study, including randomization for the timing of cervical length measurement. Exclusion Criteria: * History of preterm delivery. * Diagnosis of cervical insufficiency. * Declines or unable to consent to a transvaginal cervical length measurement. * Patients receiving care at non-Henry Ford Health radiology clinics.