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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 550 participants in total. It began in 2025-01-20 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Raminder Khangura, MD
PRINCIPAL INVESTIGATOR
Henry Ford Health
Frequently Asked Questions
Who can join the NCT06822647 clinical trial?
This trial is open to female participants only, studying Cervical Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06822647 currently recruiting?
Yes, NCT06822647 is actively recruiting participants. Contact the research team at smaster1@hfhs.org for enrollment information.
Where is the NCT06822647 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT06822647 clinical trial?
NCT06822647 is sponsored by Henry Ford Health System. The principal investigator is Raminder Khangura, MD at Henry Ford Health. The trial plans to enroll 550 participants.