Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHenry Ford Health System

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical Length Measurement at the Beginning of the Anatomy Survey

    Procedure/Surgery

    This intervention involves performing a transvaginal ultrasound to measure cervical length at the beginning of the fetal anatomy survey. The procedure includes using both grayscale and sepia-filtered imaging to evaluate adherence to the nine CLEAR criteria for accurate cervical length assessment.

  • Cervical Length Measurement at the End of the Anatomy Survey

    Procedure/Surgery

    This intervention involves performing a transvaginal ultrasound to measure cervical length at the end of the fetal anatomy survey. The procedure includes using both grayscale and sepia-filtered imaging to evaluate adherence to the nine CLEAR criteria for accurate cervical length assessment.

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: Beginning of Anatomy SurveyExperimental treatment 1 intervention
Group B: End of Anatomy SurveyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Cervical Length Measurements Meeting CLEAR Criteria at time of anatomy scan, between 18-24 weeks gestation, measured by transvaginal ultrasound

The primary outcome is the proportion of transvaginal cervical length measurements that meet all nine CLEAR (Cervical Length Education and Review) criteria for accuracy. This will assess whether timing (beginning vs. end of anatomy survey) impacts measurement reliability.

Time frame
At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).

Secondary outcomes

1

Proportion of Scans Meeting CLEAR Criteria Using Sepia-Filtered Imaging

The secondary outcome evaluates whether sepia-filtered ultrasound imaging improves adherence to the nine CLEAR criteria compared to conventional grayscale imaging. Measurements will be analyzed for both imaging modalities.

Time frame
At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).

Other outcomes

1

Interaction Between Timing and Imaging Modality on CLEAR Criteria Adherence

This exploratory outcome examines whether the timing of cervical length measurement (beginning vs. end of the anatomy survey) interacts with the imaging modality (grayscale vs. sepia-filtered) to influence adherence to the nine CLEAR criteria.

Time frame
At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant).

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