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Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

NCT04247555 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2021-07-21

No results posted yet for this study

Summary

Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Of the 14 million survivors per year, most face a lifetime of disability, including learning disabilities, visual and hearing impairments. The majority of preterm birth happen spontaneously (SPTD) which is often a multi factorial event, precocious cervical softening, shortening and dilatation are a common underlying factor. In the scope of this project the investigators propose to develop and clinically validate a new device, Cervix Monitor (CM), for detecting cervix conditions leading to SPTD and its risk assessment.

Conditions

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    collaborator OTHER

  • St. Luke's Hospital and Health Network, Pennsylvania

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Advanced Tactile Imaging, Inc.

    lead INDUSTRY

Principal Investigators

  • Vladimir Egorov, PhD · Advanced Tactile Imaging, Inc.

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247555 on ClinicalTrials.gov