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Completed

NCT Number: NCT03199079

Cervix Monitor for Elasticity and Length Measurements

Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

21 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

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About this study

The uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. Preterm delivery is closely related to a premature cervical ripening. The scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervix tissue is a collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. The primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as "hard, medium or soft". In the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult women age 21-44 years
  • Non-pregnant women, or
  • Pregnant women

Exclusion criteria

  • Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
  • Ongoing or prior radiation therapy for abdominal or pelvic cancer
  • Recent (less than four months) pelvic surgery
  • Surgically absent uterus, rectum or bladder
  • Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
  • Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
  • Known or suspected bleeding disorder
  • HIV or hepatitis B positive serology
  • Warty lesions on the vulva
  • Extensive varicose veins on the vulva
  • Active skin infection or ulceration within the vagina/vulva (Herpes infection)
  • Presence of a vaginal septum
  • Severe hemorrhoids

Treatment and study plan

Measurement

Other

Measurement of cervix elasticity and length measurements is not an intervention

Primary outcomes

  1. Cervix Elasticity

    Time frame: During examination procedure

    Young's modulus of the cervix at 4 locations. Units of measurement is kPa.

Secondary outcomes

  1. Cervix Length

    Time frame: During examination procedure

    Cervix length in mm

Sponsors and collaborators

Lead sponsor

Advanced Tactile Imaging, Inc.

Industry

Collaborators

  • Princeton Urogynecology
  • Rutgers, The State University of New Jersey

Registry information

Official study title

Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 26, 2017
Registry last updated
Oct 17, 2022

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.

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