Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06822647
Status
Recruiting
Apply to this trial

Conditions

  • Cervical Insufficiency
  • Cervical Length Measurement
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cervical Length Measurement at the Beginning of the Anatomy Survey — PROCEDURE
    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
    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.

Study Details

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.

Key Dates

Start date
Jan 20, 2025
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health New Center OneDetroitMichigan48202
Shelby Masters, MD
[email protected]
313-671-5225
Raminder Khangura, MD (PRINCIPAL_INVESTIGATOR)
Shelby Masters, MD (SUB_INVESTIGATOR)

Find similar trials in Detroit, MI

By research site
Henry Ford Health New Center One· Detroit, MI

Related Studies