Cervical Elastography
Conditions
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.
Interventions
DEVICESamsung'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.
Sponsors
Winthrop University Hospital
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of preterm Births | 24 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed