Application of Cervical Elastography in Obstetrics

NYU Langone Health

Status: Completed

Conditions: Cervical Elastography

Treatments: Device: Samsung's E-cervix technology

Study type: Observational

Funder types: Other

Identifiers

NCT03902587

18-01598

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 1 patient group

Cervical Elastography

Description:

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.

Treatment:

Device: Samsung's E-cervix technology