Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Henry Ford Health System

  lead OTHER

Principal Investigators

• Raminder Khangura, MD · Henry Ford Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-20

Primary Completion

2027-06-01

Completion

2027-07-01

Countries

• United States

Study Locations