Recruiting

Cervical Length

Sponsor:

Henry Ford Health System

Code:

NCT06822647

Conditions

Cervical Insufficiency

Preterm Birth

Cervical Length Measurement

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cervical Length Measurement at the Beginning of the Anatomy Survey

Cervical Length Measurement at the End of the Anatomy Survey

Study Details

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.

Conditions

Cervical Insufficiency

Preterm Birth

Cervical Length Measurement

Study ID

NCT06822647

Start date

Jan 20, 2025

Status verified date

Mar, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Beginning of Anatomy Survey

Participants in this arm will undergo cervical length measurement via transvaginal ultrasound at the start of the fetal anatomy survey. This timing aims to evaluate whether early measurement improves adherence to the nine CLEAR criteria for accurate cervical length assessment. Measurements will also be conducted using grayscale and sepia-filtered ultrasound imaging.

experimental: End of Anatomy Survey

Participants in this arm will undergo cervical length measurement via transvaginal ultrasound at the end of the fetal anatomy survey. This timing aims to evaluate whether late measurement improves adherence to the nine CLEAR criteria for accurate cervical length assessment. Measurements will also be conducted using grayscale and sepia-filtered ultrasound imaging.

Interventions

Cervical Length Measurement at the Beginning of the Anatomy Survey

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

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.

Primary outcome measure

  • Proportion of Cervical Length Measurements Meeting CLEAR Criteria at time of anatomy scan, between 18-24 weeks gestation, measured by transvaginal ultrasound [ Time Frame: At the time of the fetal anatomy survey, specifically 18-24wks (one-time measurement per participant). ]

Central Contacts and Locations

Central contacts

Shelby A Masters, MD

313-671-5225smaster1@hfhs.org

Raminder Khangura, MD

313-623-6412rkhangu1@hfhs.org

Locations

Henry Ford Health New Center One

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Raminder Khangura, MD

More Information

Sponsor

Henry Ford Health System

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-03-09.