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| Name | Class |
|---|---|
| Winthrop University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samsung's E-cervix technology | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of preterm Births | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| E-cervix indices | 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. | 18 Weeks, 19 Weeks, 20 Weeks, 21 Weeks, 22 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Women who present for early screening or level II ultrasound
Women who present for early screening or level II ultrasound, aged 18 to 50 years
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| Name | Affiliation | Role |
|---|---|---|
| Martin Chavez, MD | NYU Winthrop Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Winthrop Hospital | Mineola | New York | 11501 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Available upon request.
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal.
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