Clincosm LogoSign in Get a demo

Application of Cervical Elastography in Obstetrics

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03902587
Collaborator
Winthrop University Hospital (Other)
1,000
Enrollment
1
Location
22.8
Actual Duration (Months)
43.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Samsung's E-cervix technology

Study Design

Study Type:
Observational
Actual Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Application of Cervical Elastography in Obstetrics
Actual Study Start Date :
Mar 4, 2019
Actual Primary Completion Date :
Jun 5, 2020
Actual Study Completion Date :
Jan 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Cervical Elastography

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.

Device: Samsung's E-cervix technology
While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.

Outcome Measures

Primary Outcome Measures

  1. Number of preterm Births [24 Months]

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Exclusion Criteria:

  • 50 years old

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Winthrop Hospital Mineola New York United States 11501

Sponsors and Collaborators

  • NYU Langone Health
  • Winthrop University Hospital

Investigators

  • Principal Investigator: Martin Chavez, MD, NYU Winthrop Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03902587
Other Study ID Numbers:
  • 18-01598
First Posted:
Apr 4, 2019
Last Update Posted:
Feb 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Feb 3, 2021