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OpenTrials
Completed

NCT Number: NCT03902587

Application of Cervical Elastography in Obstetrics

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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Key information

Conditions

Cervical Elastography

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Number of preterm Births

    Time frame: 24 Months

Secondary outcomes

  1. E-cervix indices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Winthrop University Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 4, 2019
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.