Application of Cervical Elastography in Obstetrics

Completed

• Conditions: Cervical Elastography
• Interventions: Device: Samsung's E-cervix technology

• Registration Number: NCT03902587
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth.

During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-04
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2020-06-05
• Study Completion: 2021-01-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware

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Exclusion Criteria

• >50 years old
• prior cervical surgical procedures (i.e. LEEP procedure, cold knife cone biopsy)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical Elastography	Samsung's E-cervix technology	During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.

Primary Outcome Measures

Name	Time	Method
Number of preterm Births	24 Months

Secondary Outcome Measures

Name	Time	Method
E-cervix indices	18 Weeks, 19 Weeks, 20 Weeks, 21 Weeks, 22 Weeks	Pearson or Spearman correlation coefficients will be calculated to determine the association between the cervical length and each of the e-cervix parameters at the baseline assessment at 18-22 weeks.

Trial Locations

Locations (1)

NYU Winthrop Hospital; 🇺🇸 Mineola, New York, United States